109 Trackwise Jobs

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent thats bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com. Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegenes high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. Must Have Responsibilities The Regulatory Lead role is responsible for managing regulatory operations including initial submissions and life cycle management of products, ensuring regulatory compliance in all marketed regions. This includes: Planning and execution of new product registrations, line extensions, new indications, license renewals, variations management, and label updates throughout the life cycle of a marketed product ensuring compliance with local regulations and quality system requirements. Preparing, reviewing, and submitting regulatory dossiers for marketing authorization (MA) applications, ensuring timely and high-quality submissions in compliance with Health Authority regulations including but not limited to US, CA, EU, LATAM, APAC, GCC, and CIS countries. Managing post-approval activities, preparing and submitting applications for registration and import licenses, renewals, variations and ensuring compliance and timely renewals of regulatory commitments, while working with the client, and their local affiliates as applicable. Building and leading an excellence-focused team ensuring key operational metrics and compliance standards, maintaining high levels of accuracy and efficiency. Facilitating and cultivating relationships with local Regulatory Agencies/affiliates and Health Authorities to achieve successful outcomes and strategic alignment for submissions and schedules in each country. Ensuring Regulatory submissions and subsequent HA communication/responses within planned timelines. Voicing affiliate perspectives and needs to global and regional regulatory contacts. Maintaining regulatory tools in alignment with defined compliance metrics. Staying aware of current regulations and anticipating the implications and opportunities of changes in the regulatory environment. Communicating changes to appropriate management and cross-functional experts and implementing them locally. Addressing complex regulatory and business challenges, collaborating across functions and regions to drive favorable outcomes and acting as a subject matter expert, assisting team members with troubleshooting and presenting solutions to project-related problems. Assessing change control issued by quality or regulatory departments, evaluating regulatory impact, and developing submission strategies. Ensuring accurate documentation and management of regulatory activities and data, maintaining and updating local Regulatory Affairs SOPs in adherence to quality standards. Leading meetings with clients to discuss proposals, project status, and general business development activities. Developing and implementing long-term regulatory optimization and streamlining initiatives to enhance compliance and business efficiency. Requirements: BPharm, MPharm, Pharm D, or MSc. 8-10 years in Regulatory Affairs and Submissions Management. Experience with life-cycle management activities (e.g. Europe, USA, International would be an asset). In-depth knowledge in Regulatory Affairs and experience of working in a global regulatory environment including exposure to registration procedures (EU - CP, MRP, DCP, National etc.) and LCM strategies. Familiarity with Veeva RIMS, TrackWise, and other RIMS systems. Strong project management and documentation skills, proactive communication approach. Great customer service skills, able to work well and manage a team. Advanced skills in Microsoft Office and Adobe Professional. Good to have EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidates merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics. Locations Bangalore, KA, IN

The Supply Operation Quality (SOQ) Senior Associate will be responsible for supporting, maintaining, and implementing the Quality Management System (QMS) at the Pfizer Country Offices (PCOs) to ensure compliance with both Pfizer and Regulatory Authority expectations. The SOQ Senior Associate will work closely with relevant local stakeholders, such as Global Regulatory Sciences (GRS), Global Supply Chain (GSC), Medical, and PGS sites or ESOQ to ensure that the appropriate quality standards and systems are implemented and maintained for the product supply operation of the Pfizer India and neighboring market (Sri Lanka, Bangladesh, Nepal) business. Quality Assurance & Inspections and Internal Audit Assists with the timely implementation of applicable quality management systems (SOPs) within the PCO. Assists with ensuring initial and continuous training programs are implemented and maintained for all relevant PCO colleagues. Ensures planned, permanent & temporary changes of GMP/GDP related activities & systems are managed & documented appropriately. Ensures change actions are completed as per agreed timelines. Collects key quality performance indicators, evaluates and highlights any significant trends and identifies actions. Monitor Key Performance Indicators (KPIs) of the QMS, evaluate and highlight significant trends, and identify actions. Leads and/or participates in Quality Review Meetings as required. Provides support in the preparation and coordination of any Health Authority (HA) inspection and/or internal Pfizer audits of GMP/GDP activities in the PCO. Work with local cross functional team to define appropriate action plans to address the inspection/audit observation and tracks action implementation within the agreed timelines. Participates in the self-inspection program as an auditor and/or auditee, as required. Leads and/or participates in the Quality Risk Management program for the consistent application, documentation and communication of risks to product quality/patient safety in support of GxP activities under the remit of SOQ. Local Product Disposition & Resolution of Product Quality Perform the local release process of Products under the PCOs distribution license, as required. Supports the coordination of all Product repackaging and/or relabelling activities in the PCO and at the third-party packaging site. Review and approve documentation related to the repackaging and/or relabelling of Pfizer Product, as required. Actions Quarantine Alert Notifications promptly, as needed. Ensures quarantine shipments are managed compliantly according to procedures, as required. Provides support for any market action operation in the PCO, as required. Complaint Handling – Perform Intake and Triage, issue correspondence letter as required. Acts as a contact point for Regulatory Agency/reporter in the PCO, as required. Lead and/or participate in deviation investigations using appropriate tools and works with cross-functional teams to implement CAPAs. Notify Management of significant concerns or deviations within the QMS which have the potential to impact product, regardless of release status. Where issues originate in the PCO, assist with the preparation of QRT meetings, where required. Assist with the implementation of local actions identified during QRT. Management of relevant corrective and preventative actions (CAPA) Supplier Quality Management Execute tasks associated with the management of GxP Suppliers including qualification, quality oversight in accordance with internal and regulatory requirements for GxP activities. Assists with ensuring appropriate customer screening processes are in place to align with Pfizer and local regulations, as required. Assist with the coordination of RQA audits at the Supplier. Leadership Skills Facilitate development and execution of objectives / projects consistent with SOQ Purpose Blueprint. Development and Maintenance of Quality culture, within the team and organisation. Qualifications A minimum Tertiary Education in Science, Pharmacy or related discipline A minimum of 5 years in the pharmaceutical industry in a quality role Fluent in English (written and verbal) Experience in Quality administered systems. Excellent computer system skills – Word and Excel essential. Experience with electronic documentation control systems advantageous. Demonstrated ability to influence, when necessary, particularly with stakeholders and external parties. Experience in GMP, GDP and QMS. Technical writing and reporting Previoususe of Trackwise®, eQMS beneficial. Competencies Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy. GMP/GDP Knowledge. Trained and experienced in the total application of GMP/GDP. Auditing. Knowledge of Auditing procedures. Technical writing. Ability to lead a technical investigation and report to all levels of oganisation. Ability to write well-structured technical reports. Problem solving. Ability to use problem solving skills and tools to identify and eliminate problems as they arise. Takes initiative and ownership to deliver on time without compromising on quality. Ability to communicate effectively verbally and in writing, good negotiation and influencing skills. Acts Decisively. Makes decisions in a timely manner, makes good decisions based upon a mixture of analysis, experience, and judgment. Able to demonstrate good planning and organisation. Dealing with Ambiguity. Can effectively cope with change and handle risk and uncertainty. Emotional Intelligence. Identify, assess and control the emotions of oneself and awareness of others. Takes Responsibility. Takes personal ownership of responsibilities and outcomes while following through on commitments Work Location Assignment: Hybrid Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Quality Assurance and Control

Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to:6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.Stakeholder management and good executor with required communication.Candidate must have fair conceptual understanding on below key areasoIT QMSoValidation/QualificationoRisk management. oHandling of defects/Deviations oInvestigations oCAPA Handling oTest Management & Compliance Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc. Technical and Professional : Hands-on experience on testing tools like HP ALM, Kneat and SNOW-Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage -OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)-PAS/DCS Qualification -ISA95 High level of understanding -OT Security will be a plus.-Standalone Systems Qualifications-PAS/DCS Integrated with Manufacturing Equipment qualification. Preferred Skills: LS Domain-Computer System Validation (CSV)

As a Fortune 50 company with more than 400,000 team members worldwide, Target is an iconic brand and one of America's leading retailers. Joining Target means promoting a culture of mutual care and respect and striving to make the most meaningful and positive impact. Becoming a Target team member means joining a community that values different voices and lifts each other up . Here, we believe your unique perspective is important, and you'll build relationships by being authentic and respectful. Overview about TII At Target, we have a timeless purpose and a proven strategy. And that hasnt happened by accident. Some of the best minds from different backgrounds come together at Target to redefine retail in an inclusive learning environment that values people and delivers world-class outcomes. That winning formula is especially apparent in Bengaluru, where Target in India operates as a fully integrated part of Targets global team and has more than 4,000 team members supporting the companys global strategy and operations. A role in Finance Ops calls on your skills for quality financial and inventory reporting and accurate financials and technical accounting while providing thoughtful and responsive support, expertise and guidance to business partners. Your role will be critical to ensuring the success of Targets business initiatives and core retail operations. As a Sr. Specialist, Merch Payables, you will be responsible for reconciling store/DC invoices for prompt and accurate payment. This individual will provide extraordinary customer service to vendors and merchants by researching, resolving, and negotiating disputes relating to deductions from invoice payments in a thorough and timely manner, while ensuring protection of company assets. Additionally, you will be responsible for Invoice Reconciliation - Identifies opportunities to improve payment process. Maintains organized correspondence file of incoming, in research, and resolved disputes. Maintains working knowledge of distribution, inventory, purchase order, markdown, unit information, transportation and accounts payable systems. Vendor Relations - Provides extraordinary customer service to vendors and merchants by resolving disputes. Researches all items disputed relating to deduction for shortage, cost differences, markdown allowance reversals, return discrepancies, accounts payable violations, terms/discounts and other miscellaneous vendor issues to establish their validity. Coordinates research with the Merchants, Vendor Relations and Transportation to establish validity of deductions. Productive Partnerships - Proactive in developing productive partnerships with Merchandising, vendors and other areas of Target. Learns and understands the process and business of our customers. Process ImprovementIdentifies invoice and purchase order issues which cause reoccurring processing problems and disputed deductions, including special focus on Individual Performance Vendors (IPV). Work with supervisor to challenge status quo to resolve these continuing problems. Contact the responsible parties to correct the issue, and follow up to ensure the correction was implemented. Facilitates Communication - Maintains an excellent level of verbal and written communication between vendors and other areas of Target. Initiates, coordinates and leads meetings between teams, Merchandising, vendors and/or other areas of Target. Team and A/P Accountability - Operates in a team structured environment assisting with training and sharing expertise and information. Works with other team members and takes responsibility for covering for any or all in your business group. Participates in developing, implementing and achieving objectives/goals with the Team Lead and Supervisor that are consistent with team, department and A/P. Special Projects - Coordinates and/or participates in special projects as directed by SME, Analyst or Manager. Core responsibilities are described within this job description. Job duties may change at any time due to business needs . About you: Four-year degree or equivalent experience 1+ years of previous accounting or accounts payableexperience Strong interpersonal and communication skills (verbal and written) Excellent negotiation, organizational and problem solving skills Experience with Word, Excel, Access knowledge Strong teamwork and conflict resolution skills

Be the First to Apply Job Description Job Overview Provides first line supervision of the plant and is fully competent on all relevant operation, start-up, cleaning and checking procedures associated with the operation of at least one plant, ensuring a high quality output is achieved in a safe and effective manner. This includes monitoring and controlling the work activities of the team in a given area of plant and escalating issues effectively to Team leader or Managment Expert in Group 1 process, at least three Group 2 and Group 3 processes in core area of work. Subject matter expert supporting and leading RCF and CANDO activities in conjunction with Team Leader. Trained in Ensur, Workmate, Trackwise, SAP and Open Options. Capable of seamlessly covering for Team Leader. Flexibility to work across API Plants as required to support to the business. Competencies Investigates and reports problems on equipment and organises maintenance through direct interaction with engineers, and through escalation to Team leader or directly to management Competent to write permits and carry out risk assessments up to Hot work permit. Understands RCF investigation process and can lead thorough and timely investigation into any incident or issue on shift. Accurately documents issues on Batch documentation and can add accurate and detailed SI comments as required Understands their training targets and responsibilities and is proactively working with TL in execution of their training plan. Supports training plan of team members in their area through coaching, training and supervision of processing activities of trainees Has a high awareness of Safety and of the identified hazards in the API facility. Is able to identify safety critical issues and understands the correct actions to rectify or escalate as appropriate. Coaches and works with team in their area to build their skills in hazard identification. Leads CANDO activity in their area and monitors housekeeping and plant standards in their area of operation ensuring operation is at standard at all times. Key Responsibilities Fully competent in the completion and review of all batch related documentation, equipment / area log books, and computer transactions associated with the process. Will monitor and record all actions to the highest DI standards Responsible for the quality of work as all work is subject to GMP Issuance of permits up to hot work level Supervision of plant in absence of team leader (Trained in Ensur, Workmate, Trackwise, SAP and Open Options. Capable of seamlessly covering for Team Leader). First point of contact for operators on all production matters. Raises REW’s and DR’s as required. Progresses SOP / SOI updates Takes on a key role in new product introduction, liasing with other departments and getting involved at early stage of process. Works under some direct supervision but takes ownership and escalates issues if support is required Will manufacture a wide variety of products according to SOP’s Fully competent in the operation of at least one plant, and have significant knowledge of operations in at least one other. Selects and dispenses required material, loads equipment, making adjustments to process as necessary May carry out minor maintenance work to minimise down time, e.g., tighten flanges, change pressure gauges, replace pH probes, etc. This must be done fully following permit or written risk assessment and ensuring all procedures are followed. Required to clean and wash equipment following established procedures Leads and drives improvements with measurable benefits Investigates and reports problems on equipment and organises maintenance. Has responsibility for production and all associated paperwork and computer data entry Demonstrates leadership skills Qualifications Essential Qualifications Able to coach and train operators in process operations Wide and deep experience of API operations and of plant systems. Expert in API processing in their area of operation. Able to investigate and document any process, Quality, or ESH issue identified in their area. Understands and is competent in RCF methodologies. Relevant Experience Possesses practical knowledge of the process; which allows for effective problem resolution of production issues. About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide. Job Info Job Identification 9000 Job Category API Production Posting Date 06/26/2025, 12:59 PM Job Schedule Full time Locations Whalton Road, Morpeth, Morpeth, United Kingdom (County Level), NE61 3YA, GB

Company Description Syner-G BioPharma Group is a science-led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market, along with operational strategy and support. With a global team of 400 employees across North America and India, our goal is to help our partners navigate the complexities of product development and accelerate their journey to market. We are a leading life sciences consultancy committed to advancing human health by helping organizations bring life-saving innovations to market faster, at scale, and with the highest quality. Our team partners with a diverse range of clients across the life sciences industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital projects. We provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients to navigate complexity and deliver impactful therapies to patients worldwide. Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership, and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com Position Overview Syner-G BioPharma Group is seeking a Regulatory Affairs Consultant to support a global pharmaceutical client in the area of Chemistry, Manufacturing, and Controls (CMC), with a focus on post-approval regulatory submissions. This remote role, based in Bangalore, Chennai, Hyderabad, or Mumbai, involves providing strategic regulatory guidance and operational support to ensure compliance with FDA, EMA, and global regulatory requirements. The ideal candidate will bring strong scientific acumen, regulatory expertise, and leadership capabilities. Key Responsibilities (This list is not exhaustive and may be supplemented or changed as necessary.) Lead and manage regulatory milestones for assigned products throughout the product lifecycle Contribute to strategic regulatory discussions and decision-making processes Develop and execute CMC regulatory strategies for post-approval pharmaceutical products in compliance with US, EMA, and global regulations Author and review global CMC submissions and supporting documentation for post-approval supplements, variations, and responses to health authority queries Collaborate with internal teams and external partners to ensure compliant execution of change management activities Coordinate timely and accurate responses to regulatory authority questions (RTQs) related to CMC content Manage regulatory operational activities including organizing, tracking, and preparing submissions for publishing Conduct regulatory change control assessments and strategize post-approval implementation and reporting Review technical documents such as certificates of analysis, analytical methods, specifications, and stability data Prepare and support CMC documentation for post-approval submissions, new market registrations, and source of supply changes Maintain up-to-date knowledge of FDA, EU, and global regulations and guidance relevant to marketed products Identify and communicate potential regulatory risks and mitigation strategies Lead or support a team of 2 to 4 regulatory professionals, providing guidance and oversight on project execution Potentially contribute to pre-approval submissions (IND/CTA/IMPD) depending on experience Education QUALIFICATIONS AND REQUIREMENTS: Bachelor’s or Master’s degree in Pharmacy, Biological Sciences, Engineering, or a related field. Advanced degree preferred Experience Minimum 7 years of experience in CMC post-approval regulatory submissions or related fields such as manufacturing, quality control, or analytical development At least 5 years of experience authoring and reviewing CMC sections in Modules 1, 2, and 3 for post-approval filings Strong knowledge of US and European regulatory frameworks and ICH guidelines Experience in pharmaceutical development, drug product specifications, and stability programs Familiarity with cGMP environments and regulatory systems/tools (e.g., EDMS, Veeva Vault, Trackwise) is a plus Prior supervisory or team leadership experience is preferred Skills And Attributes Excellent written and verbal communication skills Strong organizational and project management abilities Ability to manage multiple priorities and work independently in a fast-paced environment Proactive, detail-oriented, and self-motivated with a strong work ethic Work Location: Remote position based in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations. Legal Statement Syner-G BioPharma Group is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.

Title: Lead - Store & Warehousing Date: Jun 26, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Lead Stores & Warehouse of R&D Baroda R&D Baroda Stores – Overall upkeep & management Monitor Bills processing – in time GRN processing after users’ acceptance / bill submission to SSC. Monitor material inward - receipt, delivery – Normal / Temperature controlled condition / Imported material. Monitor material outward - International & Domestic samples despatch under normal / temperature-controlled condition as per approved ARC / Rates through approved Couriers after proper evaluation of rates & Service take care of Export documentation in co-ordination with Courier, Users. Monitor Inventory management of stores-controlled lab chemicals /Commercial Solvents / Gen. Lab consumables /Housekeeping /Stationery items. Monitor manpower utilization - OT Control Monitor Stores upkeep. Monitor mailing activities - Inward / outward Monitor FRD WH area– API / Excipient stock management through Bin Card / WH upkeep. Communication to Users / HODs about procedural changes / Regulatory Updates / providing Consumption data of Stores-controlled lab-chemicals, solvents, etc. R & D Stores - documenting as per GST Rules Ensure R & D material movement document process as per GST Rules – STO generation / Invoicing through SAP system / E-way bill generation / Proper transaction closure by accounting document / cancellation of open STOs / non-dispatch invoices / return of rejected material by getting Credit notes from Vendors Monitor Asset movement with proper documentation – DRT approval / invoicing with proper material codes / follow insurance process. Monitor scrap sale transactions as per defined process with proper documentation – Invoicing under proper scrap codes as per ARC Monitor Returnable Material movement – process through Electronic Gate Pass System – Overall control – ensure timely closure. Monitor submitting of GST related reports on monthly basis to IDT Team in time. Regulatory compliance Regulatory compliances under Prohi. & Excise related licenses-DD1/DD3/RS2/MA1/AC2 as per respy. License requirement - Monitoring receipt / Storage / Issuance / stock keeping as per limit / documentation /stock register maintenance /License Renewal /Product addition under DD1/DD3 / Record keeping as per License requirement. Getting APP from IC, Gandhinagar for additional Alcohol requirement & get it approved under RS-2 License for regular usage. NDPS products handling at NDPS CWH as per NDPS SOP - monitoring receipt /issue transactions with proper documents, NDPS category wise Stock maintenance in Bin Card, Register & excel sheet properly, monthly/ quarterly/ annual Return filing correctly in time, Destruction of NDPS drug products as per NDPS SOP. Regulatory compliance under PESO License for Solvents handling – stock management within limit, License renewal. Attending Regulatory Officials visits & taking appropriate action in co-ordination with Site responsible person, updating to HOD / Site Head. Monitoring & controlling Medicinal Product Stores Activities Ensure implementation of related SOPs & compliance SOP Compliance - LMS / PMS /EDMS/TRACKWISE Systems Review receipt of RLD/Test Samples, issuance, dispatch to CROs, Destruction, cleaning records. Review change control, discrepancy note, deviation through Trackwise system. Review training for adequacy & compliance in dept. thr. LMS. Ensure to get self inspection audit complete smoothly, review observations & provide response. Act as System Owner and ensure laboratory computerized systems are validated for its intended use through its lifecycle. Ensure the laboratory computerized systems are validated in compliance with the quality policies, standards and procedures and are maintained in validated state throughout the lifecycle. Facilitate the user acceptant testing for laboratory computerized systems during validation. Review and approve Validation and life cycle documentations of computerized systems as per quality procedures. Provide support /response to internal/ external audit observations for laboratory computerized systems and ensure its compliance. Ensure resolution of identified risks related to computerized systems in a timely manner. Support the assessment and remediation of identified activities as part of various Corporate initiatives. Ensure GxP computerized systems are compliant to 21 CFR part 11 and EU Annex 11 readiness and adequate security and controls are available to ensure data security.

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Lead - Store & Warehousing Date: Jun 26, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Lead Stores & Warehouse of R&D Baroda R&D Baroda Stores – Overall upkeep & management Monitor Bills processing – in time GRN processing after users’ acceptance / bill submission to SSC. Monitor material inward - receipt, delivery – Normal / Temperature controlled condition / Imported material. Monitor material outward - International & Domestic samples despatch under normal / temperature-controlled condition as per approved ARC / Rates through approved Couriers after proper evaluation of rates & Service take care of Export documentation in co-ordination with Courier, Users. Monitor Inventory management of stores-controlled lab chemicals /Commercial Solvents / Gen. Lab consumables /Housekeeping /Stationery items. Monitor manpower utilization - OT Control Monitor Stores upkeep. Monitor mailing activities - Inward / outward Monitor FRD WH area– API / Excipient stock management through Bin Card / WH upkeep. Communication to Users / HODs about procedural changes / Regulatory Updates / providing Consumption data of Stores-controlled lab-chemicals, solvents, etc. R & D Stores - documenting as per GST Rules Ensure R & D material movement document process as per GST Rules – STO generation / Invoicing through SAP system / E-way bill generation / Proper transaction closure by accounting document / cancellation of open STOs / non-dispatch invoices / return of rejected material by getting Credit notes from Vendors Monitor Asset movement with proper documentation – DRT approval / invoicing with proper material codes / follow insurance process. Monitor scrap sale transactions as per defined process with proper documentation – Invoicing under proper scrap codes as per ARC Monitor Returnable Material movement – process through Electronic Gate Pass System – Overall control – ensure timely closure. Monitor submitting of GST related reports on monthly basis to IDT Team in time. Regulatory compliance Regulatory compliances under Prohi. & Excise related licenses-DD1/DD3/RS2/MA1/AC2 as per respy. License requirement - Monitoring receipt / Storage / Issuance / stock keeping as per limit / documentation /stock register maintenance /License Renewal /Product addition under DD1/DD3 / Record keeping as per License requirement. Getting APP from IC, Gandhinagar for additional Alcohol requirement & get it approved under RS-2 License for regular usage. NDPS products handling at NDPS CWH as per NDPS SOP - monitoring receipt /issue transactions with proper documents, NDPS category wise Stock maintenance in Bin Card, Register & excel sheet properly, monthly/ quarterly/ annual Return filing correctly in time, Destruction of NDPS drug products as per NDPS SOP. Regulatory compliance under PESO License for Solvents handling – stock management within limit, License renewal. Attending Regulatory Officials visits & taking appropriate action in co-ordination with Site responsible person, updating to HOD / Site Head. Monitoring & controlling Medicinal Product Stores Activities Ensure implementation of related SOPs & compliance SOP Compliance - LMS / PMS /EDMS/TRACKWISE Systems Review receipt of RLD/Test Samples, issuance, dispatch to CROs, Destruction, cleaning records. Review change control, discrepancy note, deviation through Trackwise system. Review training for adequacy & compliance in dept. thr. LMS. Ensure to get self inspection audit complete smoothly, review observations & provide response. Act as System Owner and ensure laboratory computerized systems are validated for its intended use through its lifecycle. Ensure the laboratory computerized systems are validated in compliance with the quality policies, standards and procedures and are maintained in validated state throughout the lifecycle. Facilitate the user acceptant testing for laboratory computerized systems during validation. Review and approve Validation and life cycle documentations of computerized systems as per quality procedures. Provide support /response to internal/ external audit observations for laboratory computerized systems and ensure its compliance. Ensure resolution of identified risks related to computerized systems in a timely manner. Support the assessment and remediation of identified activities as part of various Corporate initiatives. Ensure GxP computerized systems are compliant to 21 CFR part 11 and EU Annex 11 readiness and adequate security and controls are available to ensure data security. Apply Now » Apply Now Start applying with LinkedIn Please wait...

Trending Job Description This role is responsible for ensuring compliance with regulatory and Pharmacopoeial standards through compendia assessments, Quality Management System (QMS) oversight, and documentation preparation. It involves collaboration with global sites, vendors, and internal teams to develop quality agreements and provide support during audits and inspections. Responsibilities also include managing SOPs, monitoring QMS events, and preparing essential quality documentation and reports. Responsibilities Conduct compendia assessments for all materials used on-site to identify gaps against current Pharmacopoeial requirements and implement risk mitigation measures to ensure compliance. Develop and implement a Standard Operating Procedure (SOP) to ensure process control and long-term sustainability of compendia assessments. Collaborate with global sites to gather and analyze data on resource requirements needed for ongoing support of compendia activities. Prepare and review Annual Stability Summary Reports in compliance with regulatory and quality requirements. Develop and establish Quality Agreements with all relevant vendors and customers, ensuring alignment with regulatory and quality requirements. Track and follow up on pending TrackWise CRFs and CAPAs. Perform effectiveness checks for closed CAPAs and CRFs. Generate and maintain statistics on quality documents (e.g., deviation closures, CRFs, RAs, CAPAs). Monitor and track SOP periodic reviews across sites. Support SOP updates, including formatting checks and revision history verification. Facilitate the creation and routing of CRFs for SOP revisions. Prepare and review OOS, OOT, and lab incident investigations; initiate change controls as needed. Review planned and unplanned deviations for accuracy, completeness, and cGMP/data integrity compliance. Collaborate with site teams to resolve gaps identified during QMS event review and documentation. Engage with customers and site teams to ensure timely closure of critical QMS events. Route documents through the ENSUR application or other platforms across Piramal plants. Participate in customer audits and regulatory inspections, supporting site teams as needed. Lead or contribute to additional assignments as directed by the Head of Department (HOD). Qualifications B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent Job Info Job Identification 8769 Posting Date 06/25/2025, 10:09 AM Apply Before 07/31/2025, 10:09 AM Degree Level Bachelor's Degree Job Schedule Full time Locations Project : Piramal Agastya, PRL Agastya Pvt Ltd., LBS Marg, Kamani Junction,, Mumbai, Maharashtra, 400070, IN

Role : CMO Corporate Quality Grade : Manager Job Summary: To ensure that SUN Pharma Quality and Compliance Standards, and applicable global regulatory authorities’ requirements are met and that all SUN affiliates, CMO, Suppliers and SUN sites / Operational Units to achieve, maintain and improve the adequate level of compliance, through “Quality Oversight” and “Independent auditing and Follow-up”. Essential Job Functions: Participate in the initial evaluation of Contract Manufacturing Organizations (CMOs). Oversee and approve Quality Management System (QMS) elements reported by CMOs, including change control, deviations, incidents, Out of Specification (OOS)/Out of Trend (OOT) results, and complaint investigations. Review and approve master documents from CMOs, such as Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), specifications, validation protocols, and stability protocols. Provide support during regulatory audits at CMO sites related to SUN Pharma product approvals. Engage in critical investigations at CMO sites, including OOS results, deviations, and complaints. Review and maintain quality agreements with CMOs to ensure compliance and quality standards. Initiate QMS documents in the Trackwise system, inform the respective CMO, and track to ensure closure of initiated QMS elements. Monitor and oversee activities carried out at CMO sites to ensure compliance with SUN Pharma standards. Review executed documents from CMOs related to SUN Product to ensure accuracy and compliance. Perform batch release of SUN products manufactured at CMO sites, ensuring they meet quality standards. Make appropriate transition related to batch releases in SAP system. Coordination with the Sun Pharma warehouse for market releases of batches, including investigating temperature excursion reports during finished product transport and addressing physical damages reported by the warehouse in finished product consignments. Conduct regular visits to CMO sites, prepare detailed visit reports, and follow up on any issues identified. Review and approval of printed packaging artwork. Review and approval of formulation orders and packaging orders, followed by master recipe approval. Involvement as quality oversight during product transfer activities. Support for the project management team during the execution of exhibit/scale-up batches at the CMO site. Preparation and review of the approved vendor list for materials supplied to the CMO site by Sun Pharma. Involvement in management notifications, batch failure investigations, and recall management. Support during annual submissions to the Sun Pharma regulatory department. Involvement in the preparation of annual schedules, annual product reviews, and quality agreements. To conduct thorough GMP Audit at Vendors (manufacturers), Raw Materials, Excipients, and Packaging Materials to SUN Pharma to ensure that they always deliver high quality and standard products and remain compliant with GMP requirements. To co-ordinate with Vendor for desired documents for pre-audit preparation, logistics, resource, so as to execute successful audit as per schedule. To outline and circulate audit agenda prior to audit. The Audit Agenda shall be prepared based on reason behind conducting GMP audit, e.g. Qualification, Surveillance or For-Cause Audit. To execute on-site audit through facility visit and review of quality management systems established in various functions such as Material Management, Production & Packing, Facility & Equipment, Quality Systems and Quality Control Laboratory, including microbiology lab, as applicable. To makes sure that, SUN Manufacturing Sites, Contract Manufacturing Organisations, and Affiliate Companies are prepared for Regulatory Agency Inspections e.g. through "Mock" inspections, audits and supports activities whenever required. To ensure during audit that, non-compliances to the requirements stated in various guidelines have been identified. To communicate the outcome of CMO Audit, based on the risk associated with the patient, regulatory compliance and business risk, to facilitate making decision of Vendor Approval / Dis-approval. To prepare Planner, Schedule, Audit Report, including non-compliances and review compliance reports thereof to close the audit. This includes performing routine follow up of performed audits to ensure timely compliance and closure of the audit. To review & approved the audit report, closure, as applicable. To maintain evidences and documents related to audit. To prepare Monthly report and to highlight the key area of concerns. To participate in the trainings to update on current / upcoming regulations. To follow the Corporate Quality Policies/ Global Quality Standards (GQS) and applicable Regulatory Guidelines. Participate and execute the project work as allotted by reporting authority. To perform the risk assessment. Basic Qualification: B. Pharmacy & M. Pharmacy Experience : 12 to 15 Yrs ( Work Experience of CMO and US market required Sterile Background)

Job Title Complaint Handling and Vigilance Reporting Specialist Job Description Job title: Complaints Handling and Vigilance Specialist Your role: Works under general supervision and established processes and operational policies with independent judgement, investigates and assists in resolving highly complex complaints by monitoring product analysis findings or service analysis notes and ensures the implementation of solutions to address customer concerns efficiently. Leads the implementation of good faith efforts (GFE), diligently reviews, and analyzes supplementary data as required to fortify the investigation process and demonstrates a commitment to thoroughness and accuracy. Ensures the application of internal follow-up measures to procure further essential information necessary for reinforcing the investigation process, ensuring thoroughness and accuracy in analysis and decision-making. Establishes standards for appropriate coding to records as input for the complaints process, coordinates requests for new coding, when necessary, ensures all systems and tools are updated, and reviews and updates complaints as new codes become available. Leads the end-to-end investigation of complaints, including condensing pertinent information, analyzing findings, and presenting a concise overview of the inquiry process, including key issues identified, evidence gathered, and resolutions proposed or implemented. Reviews customer response letters (CRL) or internal responses upon concluding the investigation, utilizes effective communication and problem-solving skills, and escalates complex matters to appropriate channels for further assistance and resolution. Utilizes analytical skills to resolve medium complexity requests by exercising judgment within established procedures, analyzing complaint data, gathering additional information to assess potential product enhancements, defects, and safety issues. Handles moderate to high complexity investigations into post-market complaints and adverse events, ensures thorough and timely resolution by analyzing complaint data and documentation to identify trends, root causes, and potential product issues. Develops detailed investigation plans with clear objectives, methodologies, and timelines, conducts root cause analyses to identify underlying issues and documents findings, corrective actions, and preventive measures in comprehensive reports. Supports the training and qualification of new PMS complaint operations investigators, provides guidance, resources, and hands-on instruction to facilitate their understanding of complaint handling processes, regulatory requirements, and best practices. You're the right fit if: (4 x bullets max) Experience- 6+ Industrial experience candidate prefer from Medtech industry specialist in Diagnostic devices. Skills- Complaints Handling, Vigilance Reporting, Trackwise Experience, Education- Minimum Bachelor Degree in Any Engineering Anything else- Good communication skill, having quality mindset. How We Work Together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.

Job Title Sr. Regulatory Affairs Specialist Job Description Job title: Sr. Regulatory Affairs Specialist Your role: Job Responsibilities: Implements global regulatory strategies and roadmaps by leveraging a comprehensive understanding of the competitive market landscape and product marketing strategy to ensure alignment with organizational objectives. Works under general supervision and broad guidelines, consistently exercising independent judgment on matters of significance, ensuring adherence to company policies and regulatory requirements while maintaining high standards of performance and accountability. Demonstrates substantial understanding of regulator's role in the Quality System with good awareness of product lines, disease states, and customers, possessing general knowledge of business developed through education or past experience. Resolves a wide range of moderate complexity requests in creative ways, leads comprehensive safety risk assessments to identify potential safety incidents and regulatory non-compliance, managing these incidents in Trackwise and ensuring corrective actions are effectively implemented. Monitors and handles potential regulatory impacts on product safety, implementing continuous improvement processes within the regulatory framework and engaging with cross-functional teams to proactively manage regulatory risks. Collaborates with central and regional Regulatory Affairs teams to support establishment registration and listing, and UDI/Global Trade Identification Number (GTIN) related activities, maintaining processes for regulatory filings/ licenses and developing technical contribution. Coordinates and facilitates witness testing to ensure products comply with safety regulations, maintaining direct contact with certification bodies, test houses, and regulatory personnel in local sales organizations. Takes ownership of regulatory planning for new product introductions and product changes, assisting in the maintenance of regulatory compliance throughout the product lifecycle. Supports the development of the regulatory plan, offering guidance on risk assessment and necessary corrective actions to meet regulatory requirements, including product registrations such as CE Marking and clinical evaluations. Develops and facilitates regulatory submissions for both new and existing products/solutions, ensuring accuracy and completeness to expedite regulatory approval processes effectively, preparing regulatory justifications to support submission filing decisions. Creates, reviews, and validates marketing and labeling materials, providing support to projects and other key regulatory initiatives while ensuring compliance with regulatory guidelines and standards. Recommends enhancements in systems and processes to solve problems or improve effectiveness of job area by collaborating with other functions, making periodic or ad-hoc revisions to Regulatory SOPs and templates. Implements safety and compliance requirements for product development projects and OEM/ODM products, communicating and integrating regulatory standards into the I&D organization through memos, training sessions, and deployment strategies. Administers the compliance protocol process within PDLM and MLD, overseeing safety certifications and country-specific approvals to ensure products meet international regulatory standards. You're the right fit if: (4 x bullets max) Experience:- 8+years of experience in Regulatory Affairs Specialist in USFDA and EUMDR Skills- Dossier Preparation, Content development, Software background will be added advantage. Education.- Bachelor's / Master's Degree in any Engineering Anything else.- Good communication Skills, ready to work 30% non-medical device, Regulatory Requirements Document Auditing Data Management Regulatory Reporting Product Registrations Product Labeling Strategy Implementation Stakeholder Management Regulatory Submission Documentation Conformity Assessment Regulatory Intelligence Regulatory Compliance Risk Mitigation Strategies Continuous Improvement Project Management How We Work Together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.

Job Description Manager Product Analyst – Quality The Opportunity Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products. Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats. Our Technology centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of the company's IT operating model, Tech centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy. A focused group of leaders in each tech center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share the best practices across the Tech Centers. Role Overview As a Sr Specialist, Product Analyst – Quality, you will be responsible for driving solution design, implementation, and continuous improvement of the different QMS tools with specific alignment to the Quality business processes. Essential skills include a strong technical as well as business background, proficiency in project management methodologies (Agile, Scrum), and excellent organizational abilities. This role is positioned within the Quality Value Team, will have advanced experience in the life sciences industry, specifically Quality Management Systems and technology landscapes; specifically, Veeva Vault Quality; will have knowledge of GxP and will play a critical role during the solution design to satisfy business needs and assuring adoptability to future system scalability. What Will You Do In This Role Apply a structured approach to discover, document, and manage business processes, user and stakeholder needs, including opportunity statements, use cases, insights, and requirements. Gather insight into user journeys, behavior, motivation, and pain points. Expose unarticulated problems and unmet needs. Document business process, business, and user needs in the form of problem statements to make up the backlog. Facilitate the “how” with the Development team. Gain expertise in the business area. Manage business analysis per agreed priority backlog items in JIRA. Participating in impact assessment activities, reviewing proposed changes and ensuring impact is understood. Deliver product enhancements through agreed backlog process to ensure Quality solutions evolve to meet business needs. Ensure Quality solutions remain compliant as a Validated Solution through verification testing, documentation, and validation efforts. Provide overall leadership, guidance, and management of all aspects of a given solution, including requirements gathering, enhancements delivery plan, and implementation. Initiate projects including defining a scope/charter, identifying stakeholders, and establishing governance. Act as a bridge between Business SMEs, technical teams, and non-technical stakeholders. Communicate delivery status, solution health, risks, and issues to all parties involved and ensure that everyone is aligned and informed. Conduct product status meetings and present updates to stakeholders and senior management. Evaluate delivery performance and implement continuous improvement practices. Understand the technical aspects as well as business process impacts to make informed decisions, provide guidance, and communicate effectively with the development team. This includes having a deep understanding of the QMS business processes, technology stack, architecture, and potential technical challenges. Work closely with the Product Owner to prioritize and refine the product backlog, ensuring that the team focuses on delivering the most valuable features. Identify potential risks and develop mitigation strategies. Proactively address issues that could impact project success. What Should You Have Minimum Level of Education Required Bachelor’s Degree in Computer Science, Engineering, MIS, and Science OR in a related field. The job requires a solid academic background in how Information Technology supports the delivery of business objectives. Preferred Level of Education Veeva Certifications (Veeva Vault/Vault Quality Suite/ QMS). The role holder has completed the Certified Vault Training and is up to date. 3+ years of experience in technical project management, with a strong understanding of project management methodologies (Agile, Scrum, Waterfall). Understanding Quality Management System Capabilities (Audit/Inspection management, CAPA management, Deviations management, Complaint management). Experience in solution delivery with GMP systems. Experience with architecture, integration, interfaces, portals, and/or analytics. Understanding of Systems Development Life Cycle (SDLC), and current Good Manufacturing Practice (cGMP) processes. Knowledge and experience with QMS relevant tools like Veeva Vault Quality and TrackWise. Proven experience leading complex technical projects in a fast-paced environment. Strong technical background with knowledge of software development, systems integration, or related areas. Excellent organizational, leadership, and decision-making skills. Strong analytical and problem-solving abilities. Effective communication and interpersonal skills to liaise with cross-functional teams. Ability to manage multiple projects simultaneously and adapt to changing priorities Who We Are We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What We Look For Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are intellectually curious, join us—and start making your impact today. #HYDIT2025 Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Hybrid Shift Valid Driving License Hazardous Material(s) Required Skills Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs Preferred Skills Job Posting End Date 07/24/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R352361

Title: Manager 1 - Production Scheduling Date: Jun 23, 2025 Location: Paonta Sahib - Operations Company: Sun Pharmaceutical Industries Ltd Manager 1 – Production Scheduling Location: Paonta Sahib Education: B. Pharma/M. Pharma/ MSc Experience: 12+ years in Formulation To ensure Formulation & Process Orders along with Batch Production Records for all Blocks in Plant are issued as per schedule by ensuring Good documentation practices. To co-ordinate effectively with all stakeholders i.e. PDL, RA, QC for availability of Recipes, LP's, RM & PM Releases to meet production plan. To ensure allocation of batches in respective SKU's as per commits. To ensure smooth functioning of Production by ensuring RM/PM Recipe/LP I s are available timey to run Packing Lines as per Schedule. To ensure allocation & packing of critical & NIL supply SKU's To maintain System Hygiene by timely closure of unwanted Process Orders so as to avoid hampering of MRP run. To attend S&OP meetings & respond to market queries. To provide additional testing request as per desired market specification. To provide Code to code request to meet market requirement based on approval from all stake holders. To ensure Inventory Reduction and Control To keep track of Non Moving & Rejected items. To provide Batch specific details for procurement of Batch Specific Foil To ensure WIP control and RM/& PM short expiry materials, nearing expiry are consumed to Avoid consumption of fresh items, Retest times are given priorities for releases. To raise Locking & Unlocking forms request as per INTM Linkage request details provided by Production QMS. To complete task assigned in TrackWise and time to time Revision of SOP007691 Procedure of Batch Production Record

Job Description Manager Product Analyst – Quality The Opportunity Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products. Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats. Our Technology centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of the company's IT operating model, Tech centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy. A focused group of leaders in each tech center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share the best practices across the Tech Centers. Role Overview As a Sr Specialist, Product Analyst – Quality, you will be responsible for driving solution design, implementation, and continuous improvement of the different QMS tools with specific alignment to the Quality business processes. Essential skills include a strong technical as well as business background, proficiency in project management methodologies (Agile, Scrum), and excellent organizational abilities. This role is positioned within the Quality Value Team, will have advanced experience in the life sciences industry, specifically Quality Management Systems and technology landscapes; specifically, Veeva Vault Quality; will have knowledge of GxP and will play a critical role during the solution design to satisfy business needs and assuring adoptability to future system scalability. What Will You Do In This Role Apply a structured approach to discover, document, and manage business processes, user and stakeholder needs, including opportunity statements, use cases, insights, and requirements. Gather insight into user journeys, behavior, motivation, and pain points. Expose unarticulated problems and unmet needs. Document business process, business, and user needs in the form of problem statements to make up the backlog. Facilitate the “how” with the Development team. Gain expertise in the business area. Manage business analysis per agreed priority backlog items in JIRA. Participating in impact assessment activities, reviewing proposed changes and ensuring impact is understood. Deliver product enhancements through agreed backlog process to ensure Quality solutions evolve to meet business needs. Ensure Quality solutions remain compliant as a Validated Solution through verification testing, documentation, and validation efforts. Provide overall leadership, guidance, and management of all aspects of a given solution, including requirements gathering, enhancements delivery plan, and implementation. Initiate projects including defining a scope/charter, identifying stakeholders, and establishing governance. Act as a bridge between Business SMEs, technical teams, and non-technical stakeholders. Communicate delivery status, solution health, risks, and issues to all parties involved and ensure that everyone is aligned and informed. Conduct product status meetings and present updates to stakeholders and senior management. Evaluate delivery performance and implement continuous improvement practices. Understand the technical aspects as well as business process impacts to make informed decisions, provide guidance, and communicate effectively with the development team. This includes having a deep understanding of the QMS business processes, technology stack, architecture, and potential technical challenges. Work closely with the Product Owner to prioritize and refine the product backlog, ensuring that the team focuses on delivering the most valuable features. Identify potential risks and develop mitigation strategies. Proactively address issues that could impact project success. What Should You Have Minimum Level of Education Required Bachelor’s Degree in Computer Science, Engineering, MIS, and Science OR in a related field. The job requires a solid academic background in how Information Technology supports the delivery of business objectives. Preferred Level of Education Veeva Certifications (Veeva Vault/Vault Quality Suite/ QMS). The role holder has completed the Certified Vault Training and is up to date. 3+ years of experience in technical project management, with a strong understanding of project management methodologies (Agile, Scrum, Waterfall). Understanding Quality Management System Capabilities (Audit/Inspection management, CAPA management, Deviations management, Complaint management). Experience in solution delivery with GMP systems. Experience with architecture, integration, interfaces, portals, and/or analytics. Understanding of Systems Development Life Cycle (SDLC), and current Good Manufacturing Practice (cGMP) processes. Knowledge and experience with QMS relevant tools like Veeva Vault Quality and TrackWise. Proven experience leading complex technical projects in a fast-paced environment. Strong technical background with knowledge of software development, systems integration, or related areas. Excellent organizational, leadership, and decision-making skills. Strong analytical and problem-solving abilities. Effective communication and interpersonal skills to liaise with cross-functional teams. Ability to manage multiple projects simultaneously and adapt to changing priorities Who We Are We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What We Look For Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are intellectually curious, join us—and start making your impact today. #HYDIT2025 Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Hybrid Shift Valid Driving License Hazardous Material(s) Required Skills Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs Preferred Skills Job Posting End Date 07/24/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R352363

Job Description Manager Product analyst – Quality The Opportunity Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products. Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats. Our Technology centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of the company's IT operating model, Tech centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy. A focused group of leaders in each tech center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share the best practices across the Tech Centers. Role Overview As a Sr Specialist, Product Analyst – Quality, you will be responsible for driving solution design, implementation, and continuous improvement of the different QMS tools with specific alignment to the Quality business processes. Essential skills include a strong technical as well as business background, proficiency in project management methodologies (Agile, Scrum), and excellent organizational abilities. This role is positioned within the Quality Value Team, will have advanced experience in the life sciences industry, specifically Quality Management Systems and technology landscapes; specifically, Veeva Vault Quality; will have knowledge of GxP and will play a critical role during the solution design to satisfy business needs and assuring adoptability to future system scalability. What Will You Do In This Role Apply a structured approach to discover, document, and manage business processes, user and stakeholder needs, including opportunity statements, use cases, insights, and requirements. Gather insight into user journeys, behavior, motivation, and pain points. Expose unarticulated problems and unmet needs. Document business process, business, and user needs in the form of problem statements to make up the backlog. Facilitate the “how” with the Development team. Gain expertise in the business area. Manage business analysis per agreed priority backlog items in JIRA. Participating in impact assessment activities, reviewing proposed changes and ensuring impact is understood. Deliver product enhancements through agreed backlog process to ensure Quality solutions evolve to meet business needs. Ensure Quality solutions remain compliant as a Validated Solution through verification testing, documentation, and validation efforts. Provide overall leadership, guidance, and management of all aspects of a given solution, including requirements gathering, enhancements delivery plan, and implementation. Initiate projects including defining a scope/charter, identifying stakeholders, and establishing governance. Act as a bridge between Business SMEs, technical teams, and non-technical stakeholders. Communicate delivery status, solution health, risks, and issues to all parties involved and ensure that everyone is aligned and informed. Conduct product status meetings and present updates to stakeholders and senior management. Evaluate delivery performance and implement continuous improvement practices. Understand the technical aspects as well as business process impacts to make informed decisions, provide guidance, and communicate effectively with the development team. This includes having a deep understanding of the QMS business processes, technology stack, architecture, and potential technical challenges. Work closely with the Product Owner to prioritize and refine the product backlog, ensuring that the team focuses on delivering the most valuable features. Identify potential risks and develop mitigation strategies. Proactively address issues that could impact project success. What Should You Have Minimum Level of Education Required Bachelor’s Degree in Computer Science, Engineering, MIS, and Science OR in a related field. The job requires a solid academic background in how Information Technology supports the delivery of business objectives. Preferred Level of Education Veeva Certifications (Veeva Vault/Vault Quality Suite/ QMS). The role holder has completed the Certified Vault Training and is up to date. 3+ years of experience in technical project management, with a strong understanding of project management methodologies (Agile, Scrum, Waterfall). Understanding Quality Management System Capabilities (Audit/Inspection management, CAPA management, Deviations management, Complaint management). Experience in solution delivery with GMP systems. Experience with architecture, integration, interfaces, portals, and/or analytics. Understanding of Systems Development Life Cycle (SDLC), and current Good Manufacturing Practice (cGMP) processes. Knowledge and experience with QMS relevant tools like Veeva Vault Quality and TrackWise. Proven experience leading complex technical projects in a fast-paced environment. Strong technical background with knowledge of software development, systems integration, or related areas. Excellent organizational, leadership, and decision-making skills. Strong analytical and problem-solving abilities. Effective communication and interpersonal skills to liaise with cross-functional teams. Ability to manage multiple projects simultaneously and adapt to changing priorities Who We Are We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What We Look For Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are intellectually curious, join us—and start making your impact today. #HYDIT2025 Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Hybrid Shift Valid Driving License Hazardous Material(s) Required Skills Asset Management, Benefits Management, Business, Management Process, Management System Development, Product Lifecycle, Product Management, Quality Management, Requirements Management, Social Collaboration, Stakeholder Relationship Management, Strategic Planning, System Designs Preferred Skills Job Posting End Date 07/24/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R350703

Job Description Ensure the review & release of QC sample analysis, AnalyticalMethod validation, Cleaning Method Validation, Hold time sample, market complaintsrecord, instrument calibration records, Analyst qualification record andMiscellaneous study report. 2. Review of electronic data generated throughlaboratory instruments and review of executed analytical workbooks / Test Datasheet for In- process, Finished product, Stability, working standard,Analytical Method validation, Method transfer, Cleaning Method Validation, Holdtime sample, market complaints record, instrument calibration records, Analystqualification record and Miscellaneous study reports -- Suraj 3. Providedecision of acceptance / rejection of stability samples, Raw material,Packaging materials, instrument calibration lots, water sample lots &working standard records on the basis of analysis and ensuring entries intosystem. 4. Logging, evaluation and implementation of the incidents, deviations,change control & CAPA. 5. Investigation and root cause analysis requiredfor the critical incidents and failures. 6. Responsible to check the onlinedocumentation & ensure compliance to systems and procedures in QualityControl 7. Preparation and review of Standard Operating Procedures (SOPs) ofGlenmark Pharmaceuticals Limited. 8. Checking & approval of COA’s for Rawmaterial & Packaging materials. 9. Timely and effective communication andescalation of quality issues to the appropriate levels of management. 10.Issuance of log books / registers / formats to Quality control 11. Issuance ofFormats/TES in case of SAP shutdown. 12. Responsible to attend the trainingsessions as per schedule (TNI) or un-schedule training sessions. 13.Responsible to ensure the team members are trained by providing training onrelevant SOPs 14. Review of recent updation of the test methods as perPharmacopoeial / regulatory requirements. 15. LER & Extraneous peak Investigationreview & approval of LER. 16. Review of stability data compilation 17. ITApplications: Usage of QMS related T. Codes in SAP, Open Text, MS Office,Acrobat Reader, Departmental Drive, Skype, Outlook, GENESIS, HR Portal, ASPIRELearning Management System, Trackwise and Internet. 18. Maintain Environment,Health and Safety system as per ISO 14001:2015 & ISO 45001:2018. 19. Anyother responsibility assigned by Department Head.

Job Title : Sr. Executive - Perform Program for Alternate Source implementation Qualification: Graduate / Post Graduate in Pharmacy with 5-8 years of experience in Pharmaceutical Quality Assurance or Production Candidate having sound experience in documentation as well as execution of oral solid dosage Production process starting from Dispensing to Secondary packing. 5-8 years of exposure either in Quality Assurance (IPQA, QMS) or Manufacturing/Production section including Manufacturing or packing section Specific Requirements Experience in IPQA, QMS or Production activities of Solid Dosage Form (Tablets). Worked with EU regulatory-approved pants. Quality assurance (IPQA, QMS) Operating SAP/ERP and QMS tools (Trackwise, Quality forward) Compilation and Documentation of Pharmaceutical documents Communication, coordination, Tracking and Exposure to Shop floor Job Summary Key member of Perform Program function in Site Strategy Execution team. Executive/Sr. Executive - Alternate Source implementation is primarily responsible to support Perform Program Manager for successful Planning and execution by ensuring end-to-end tracking and coordination of project activities identified for ongoing / new projects such as Product Transfer, New Development, Product supply switch, New product launch and alternate source implementation in line with Zentiva roadmap to deliver ‘on time in full’ commitments from LRP and budget by engaging relevant functions and operations in the organization. The role will be as well accountable to sustain overall tracking and coordination system (reporting and governance) established as a common way of working and measure across the various functions and sites involved. All above activities shall be performed in line with Zentiva’s compliance requirement (Quality and Safety). Strong communication and coordination skills within the team and cross-functional departments Process knowledge and awareness with Quality/QMS tools Knowledge of SAP and QMS tools (eDMS, Trackwise, Quality Forward) Compilation and documentation of Pharmaceutical documentation Key Accountabilities Process Responsible to support Perform Program Manager by ensuring end-to-end tracking and coordination of Product Transfer, New Development, Supply switch, Launch and alternate supplier implementation activities for the site, to achieve timely project completion which can support growth.. Management of all identified project actions at site using project plan and to check their accomplishment for successful project execution. Participation and engagement with site as well as global project team beginning from Product feasibility, Technology transfer till launch/supply switch for the new development/internalize transfer products and alternate source implementation identified for the products concerned. Understanding communication of relevant information associated to projects received from the Development / Portfolio team to other cross functional team members of the technical team. Engaging project team members through regular calls and steering regular project team meetings across the respective organizational group. Responsible to Cooperates with site as well as external stakeholders, transfer team (both global and site) for identified projects, i.e. Product Transfer, New Development, COGs optimization and capacity utilization, Alternate supplier implementation, Product life cycle management and process optimization. Participating and actively managing regular, cross-functional Launch Management meetings, to ensure timely delivery of work packages of all involved stakeholders Effective and successful communication with all stakeholders Support continuous improvement activities by participating in cost engineering techniques and operational excellence techniques, identifying inefficiencies and cost optimisation opportunities. Other activities priority assigned by Perform Program Manager. Compliance Adherence to Zentiva Quality, HSE and organizational compliance Ensure timely completion of training in order to comply with Quality and HSE compliance across all levels Capture good practices across the organization (techniques, processes, management etc..) Share good practices across the organization Feedback to process / function owners the new standards requirement for future development of processes / products Monitoring And Improvement Provides project updates and reports on project progress to both site as well as global management using Process flow Tracker or suitable project tracker established. Coordinating with Shop floor team members for Transfer project / source change related activities on the shop floor in production areas. Coordination and Follow-up with cross functional project team including Production, Quality, Warehouse – Supply chain, Procurement and Controlling according to the action items defined and maintain current status in the tracker. Preparation and timely revision of project-related documentation and databases, e.g. Product Transfer checklist, Product transfer Protocol and Report and other project related documentation. Initiating, Tracking and management of Project related Change controls, actions identified, Extension of the change control actions as well as closure. Ensuring availability of Supplier documentation and other prerequisites for new API/RM required for respective project. Coordination with responsible for ZMID, BOM and material sourcing (PR/PO tracking) and other associated activities for Projects Periodic reporting of KPIs defined Report / track project achievement/challenges to identify any actions required.

Job Title: Sr. Executive - Perform Program for Alternate Source implementation Qualification: Graduate / Post Graduate in Pharmacy with 5-8 years of experience in Pharmaceutical Quality Assurance or Production Candidate having sound experience in documentation as well as execution of oral solid dosage Production process starting from Dispensing to Secondary packing. 5-8 years of exposure either in Quality Assurance (IPQA, QMS) or Manufacturing/Production section including Manufacturing or packing section Specific Requirements: Experience in IPQA, QMS or Production activities of Solid Dosage Form (Tablets). Worked with EU regulatory-approved pants. Quality assurance (IPQA, QMS) Operating SAP/ERP and QMS tools (Trackwise, Quality forward) Compilation and Documentation of Pharmaceutical documents Communication, coordination, Tracking and Exposure to Shop floor Job Summary: Key member of Perform Program function in Site Strategy Execution team. Executive/Sr. Executive - Alternate Source implementation is primarily responsible to support Perform Program Manager for successful Planning and execution by ensuring end-to-end tracking and coordination of project activities identified for ongoing / new projects such as Product Transfer, New Development, Product supply switch, New product launch and alternate source implementation in line with Zentiva roadmap to deliver ‘on time in full’ commitments from LRP and budget by engaging relevant functions and operations in the organization. The role will be as well accountable to sustain overall tracking and coordination system (reporting and governance) established as a common way of working and measure across the various functions and sites involved. All above activities shall be performed in line with Zentiva’s compliance requirement (Quality and Safety). Strong communication and coordination skills within the team and cross-functional departments Process knowledge and awareness with Quality/QMS tools Knowledge of SAP and QMS tools (eDMS, Trackwise, Quality Forward) Compilation and documentation of Pharmaceutical documentation KEY ACCOUNTABILITIES Process Responsible to support Perform Program Manager by ensuring end-to-end tracking and coordination of Product Transfer, New Development, Supply switch, Launch and alternate supplier implementation activities for the site, to achieve timely project completion which can support growth.. Management of all identified project actions at site using project plan and to check their accomplishment for successful project execution. Participation and engagement with site as well as global project team beginning from Product feasibility, Technology transfer till launch/supply switch for the new development/internalize transfer products and alternate source implementation identified for the products concerned. Understanding communication of relevant information associated to projects received from the Development / Portfolio team to other cross functional team members of the technical team. Engaging project team members through regular calls and steering regular project team meetings across the respective organizational group. Responsible to Cooperates with site as well as external stakeholders, transfer team (both global and site) for identified projects, i.e. Product Transfer, New Development, COGs optimization and capacity utilization, Alternate supplier implementation, Product life cycle management and process optimization. Participating and actively managing regular, cross-functional Launch Management meetings, to ensure timely delivery of work packages of all involved stakeholders Effective and successful communication with all stakeholders Support continuous improvement activities by participating in cost engineering techniques and operational excellence techniques, identifying inefficiencies and cost optimisation opportunities. Other activities priority assigned by Perform Program Manager. Compliance Adherence to Zentiva Quality, HSE and organizational compliance Ensure timely completion of training in order to comply with Quality and HSE compliance across all levels Capture good practices across the organization (techniques, processes, management etc..) Share good practices across the organization Feedback to process / function owners the new standards requirement for future development of processes / products Monitoring and Improvement: Provides project updates and reports on project progress to both site as well as global management using Process flow Tracker or suitable project tracker established. Coordinating with Shop floor team members for Transfer project / source change related activities on the shop floor in production areas. Coordination and Follow-up with cross functional project team including Production, Quality, Warehouse – Supply chain, Procurement and Controlling according to the action items defined and maintain current status in the tracker. Preparation and timely revision of project-related documentation and databases, e.g. Product Transfer checklist, Product transfer Protocol and Report and other project related documentation. Initiating, Tracking and management of Project related Change controls, actions identified, Extension of the change control actions as well as closure. Ensuring availability of Supplier documentation and other prerequisites for new API/RM required for respective project. Coordination with responsible for ZMID, BOM and material sourcing (PR/PO tracking) and other associated activities for Projects Periodic reporting of KPIs defined Report / track project achievement/challenges to identify any actions required.

Role Objective: A key objective of this profile is to ensure the effective planning, execution, and documentation of validation and calibration activities, in compliance with regulatory standards and internal policies. The role focuses on maintaining high-quality standards, managing internal and external audits, and ensuring adherence to ISO 13485 and other relevant quality management standards. Additionally, the role supports continuous quality improvement initiatives and ensures that validation activities align with business needs and regulatory requirements. Desired Candidate Profile: Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field. A minimum of 6 years of experience in Quality Assurance within the medical device or pharmaceutical industry. Strong knowledge of validation processes, quality systems, and regulatory standards, such as MDD 93/42/EEC and ISO13485. Experience managing CAPA (Corrective and Preventive Action), conducting risk assessments, and handling internal/external audits. Proven ability to manage validation projects, including scheduling and team coordination. Excellent communication, organizational, and analytical skills. Role & Responsibilities: Plan and execute validation and calibration activities according to the approved schedule, including HVAC, process, transport, sterilization, equipment qualification, and temperature mapping. Coordinate the preparation of PR, PO, material issuance, and service entries for validation-related activities. Provide training to relevant personnel on validation processes and artwork review. Review and compile validation reports from external agencies, ensuring timely approval and payment processing. Verify vendor agreements and certifications, ensuring timely renewals and regulatory compliance. Oversee and ensure the proper execution of QMS activities, including document management and software use (e.g., TrackWise). Participate in line clearance and IPQA (In-Process Quality Assurance) activities as needed. Prepare and review GMP (Good Manufacturing Practice) documents such as SOPs, protocols, and other required documents. Ensure adherence to ISO13485 standards and other relevant regulations. Collaborate with the regulatory department to provide validation and calibration documents as needed for regulatory submissions. Participate in internal and external audits, ensuring timely and accurate documentation submission. Manage PR initiation and closure in TrackWise for qualification and calibration activities. Prepare and execute equipment and utility validation documents as per schedule. Functional Skills Required Expertise in Quality Management Systems (QMS) and validation processes. In-depth knowledge of MDR and other relevant regulatory frameworks. Strong proficiency in CAPA management, auditing, and risk assessment. Technical expertise in process, equipment, and product validation. Ability to manage multiple validation projects and meet strict deadlines. Behavioral Skills Required Strong team management and leadership abilities. Excellent problem-solving and analytical skills. High attention to detail and a commitment to accuracy. Strong interpersonal and communication skills. Ability to collaborate effectively across teams and departments. A proactive approach to continuous improvement and maintaining high-quality standards. Team Size to be Handle: Manage the team of 2-3 team members of Validation & QMS, reporting to AGM-QA. Learn more at: https://www.biotechhealthcare.com Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Planning and executing various analytical method development, validation for new products, comprehensive testing of API and finished dosages with all established regulatory and compliance and safety requirements. Review of laboratory data, instrument logbook and reports wherever applicable. Initiation of departmental CCR's and tracking the progress to execute the proposed changes through QMS system. Preparation of TAP (Transfer of Analytical Procedures) protocol and Report for various sites. Procuring respective samples and Impurities accordingly. Planning and executing the assigned TAP projects to various sites. Preparation, maintenance and archival of regulatory submission documentation like SOP, protocols, reports for method development and validation. Job Responsibilities Prepares working plan for assigned projects and provides timeline to Manager. Develops stability indicative analytical methods for drug substance and finished product Responsible for all activities in Analytical Development, including cGLP, documentation and implementation of departmental quality systems. Applies AQbD approach to analytical method development where applicable. Responsible for protocol preparation, planning, execution, review and report preparation of various analytical method validation parameters. Ensures analytical methods validation is conducted according to approved validation protocols in a timely manner with accuracy and precision in compliance of laboratory SOP and guidelines. Responsible for method verifications and publishing of analytical methods. Maintenance and archival of analytical method validation documents. Performs all analytical tests for drug substance, including assay, related compounds, identifications and wet chemistry for API evaluation. Performs all analytical tests for PE/PO samples, including assay, degradation products and dissolution. Performs all analytical tests for API releasing, including assay, degradation products, dissolution and physical testing. Conducts other tests required for dosage submissions. Conducts lab investigations for OOS and OOT results. Raising Change control for various analytical activities (Method SOP and department SOPs) by QMS trackwise To prepare General, Operation and Calibration Standard Operating Procedures. Responsible for initiation, execution and completion of technology transfer and collaborative validation activities of analytical methods to and / or from other departments of Apotex wherever applicable. Responsible for technology transfer and Transfer of analytical procedures activity to support the supervisor. Communicating the requirements for the Leaders and within the team members for effective cGLP procedures and departmental quality systems to achieve all outcomes. With minimal guidance, performs troubleshooting on complex issues with respect to the stability of drug substances and drug products. To participate in the mandatory trainings to execute the day to day job responsibilities. Assist in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GLP. Develops and maintain strong relationships within Analytical R&D to ensure that the projects are delivered on time. Practice and up-gradation of knowledge with respect to cGMP. Performs all work in accordance with all established regulatory and compliance and safety requirements. Participates in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GMP requirements. Ensures all instruments assigned with responsibility within group/department are well maintained. Performs the calibration of instruments in Analytical R&D and ensures the compliance as per cGLP requirements. Work as a member of a team to achieve all outcomes. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education A graduate/post graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field. Knowledge, Skills and Abilities knowledge of the instrumentation such as HPLC, GC, UV, IR spectrophotometer and dissolution apparatus, wet chemistry and analytical bench techniques. Knowledge in HPLC method development and method validation. Knowledge on preparation and review of various documents like SOP's, Formats, Protocols, Reports, analytical data, investigation and deviation reports. Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities Should possess troubleshooting knowledge on Instruments and analysis. Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems. Working knowledge of LIMS is an asset. Good written and verbal English communication skills. Experience BSc with 5 years or MSc with 4 years or PhD with 2 years’ experience in a pharmaceutical lab in an R&D environment. Chromatographic method development and validation. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com. Job Summary Planning and executing various analytical method development, validation for new products, comprehensive testing of API and finished dosages with all established regulatory and compliance and safety requirements. Review of laboratory data, instrument logbook and reports wherever applicable. Initiation of departmental CCR's and tracking the progress to execute the proposed changes through QMS system. Preparation of TAP (Transfer of Analytical Procedures) protocol and Report for various sites. Procuring respective samples and Impurities accordingly. Planning and executing the assigned TAP projects to various sites. Preparation, maintenance and archival of regulatory submission documentation like SOP, protocols, reports for method development and validation. Job Responsibilities Prepares working plan for assigned projects and provides timeline to Manager. Develops stability indicative analytical methods for drug substance and finished product Responsible for all activities in Analytical Development, including cGLP, documentation and implementation of departmental quality systems. Applies AQbD approach to analytical method development where applicable. Responsible for protocol preparation, planning, execution, review and report preparation of various analytical method validation parameters. Ensures analytical methods validation is conducted according to approved validation protocols in a timely manner with accuracy and precision in compliance of laboratory SOP and guidelines. Responsible for method verifications and publishing of analytical methods. Maintenance and archival of analytical method validation documents. Performs all analytical tests for drug substance, including assay, related compounds, identifications and wet chemistry for API evaluation. Performs all analytical tests for PE/PO samples, including assay, degradation products and dissolution. Performs all analytical tests for API releasing, including assay, degradation products, dissolution and physical testing. Conducts other tests required for dosage submissions. Conducts lab investigations for OOS and OOT results. Raising Change control for various analytical activities (Method SOP and department SOPs) by QMS trackwise To prepare General, Operation and Calibration Standard Operating Procedures. Responsible for initiation, execution and completion of technology transfer and collaborative validation activities of analytical methods to and / or from other departments of Apotex wherever applicable. Responsible for technology transfer and Transfer of analytical procedures activity to support the supervisor. Communicating the requirements for the Leaders and within the team members for effective cGLP procedures and departmental quality systems to achieve all outcomes. With minimal guidance, performs troubleshooting on complex issues with respect to the stability of drug substances and drug products. To participate in the mandatory trainings to execute the day to day job responsibilities. Assist in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GLP. Develops and maintain strong relationships within Analytical R&D to ensure that the projects are delivered on time. Practice and up-gradation of knowledge with respect to cGMP. Performs all work in accordance with all established regulatory and compliance and safety requirements. Participates in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GMP requirements. Ensures all instruments assigned with responsibility within group/department are well maintained. Performs the calibration of instruments in Analytical R&D and ensures the compliance as per cGLP requirements. Work as a member of a team to achieve all outcomes. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education A graduate/post graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field. Knowledge, Skills and Abilities knowledge of the instrumentation such as HPLC, GC, UV, IR spectrophotometer and dissolution apparatus, wet chemistry and analytical bench techniques. Knowledge in HPLC method development and method validation. Knowledge on preparation and review of various documents like SOP's, Formats, Protocols, Reports, analytical data, investigation and deviation reports. Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities Should possess troubleshooting knowledge on Instruments and analysis. Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems. Working knowledge of LIMS is an asset. Good written and verbal English communication skills. Experience BSc with 5 years or MSc with 4 years or PhD with 2 years’ experience in a pharmaceutical lab in an R&D environment. Chromatographic method development and validation. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Handled SAFe and Agile-based delivery with strong skills in requirement elicitation, Jira project management, and user story writing. Translated complex business requirements into Use Cases, User Stories , and Process/Workflow Diagrams . Experience in using Jira, documents, epics, user stories, risks, issues, and defects. Mentored development teams; facilitated Sprint Planning, Retrospectives, Daily Stand-ups , and presented in Sprint Demos and Reviews. Created BRD, FRD, Features, Roadmaps, User manuals ; involved in development and testing teams. Supported international clients (Airlines, Retail, Insurance), including a 3-month on-site collaboration in Europe . Maintained the Product Backlog and coordinated with the clients UX team. Supported Go-live activities , complaint handling, and resolution to improve customer satisfaction. Started as a UI developer , contributing to chatbot design and generative AI advancements . Experience with Salesforce-related applications (TrackWise, STAR). Role & responsibilities Preferred candidate profile

Mode of Work : Hybrid Location : Pune, Bangalore, Hyderabad, Pune, Noida, Gurgaon, Chennai, Kolkata, Skill Set : Computer System Validation (CSV ), Veeva Vault , Trackwise , Argus The opportunity Were looking for Senior with expertise in Computer System Validation and stakeholder management to join our Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach. Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement. Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements. Skills and attributes for success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills. Interested Candidates can send their cv's to frichardson@allegisglobalsolutions.com Looking for candidates from Pharma Companies. Regards, Franklin.A

Req ID: 329333 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. We are currently seeking a Trakwise support to join our team in NOIDA, Uttar Pradesh (IN-UP), India (IN). Trakwise support resource Trackwise Support for onprimse and Digital version of trackwise for a lifesciences client. Need overall 4/ 5 yrs experience in supporting Trakwise both the on-prime and Digital versions. Work indepndently on the support issues, including admin activities and enhacements that are asigned. Minimum 4-5 years of administering and supporting applications/solutions. Strong understanding of drug discovery or related life science industry experience is required. Experience with scheduling systems is a plus. Data visualization, workflows and reporting tools (Salesforce Dataloader, flows, admin module) Strong knowledge in GLP process and GXP processCommunciate with US/ UK based client based teams. Good communciation. Work in 3pm to 12am(Midnight) shift About NTT DATA NTT DATA is a $30 billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long term success. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure and connectivity. We are one of the leading providers of digital and AI infrastructure in the world. NTT DATA is a part of NTT Group, which invests over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. Visit us at us.nttdata.com NTT DATA endeavors to make https://us.nttdata.com accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact us at https://us.nttdata.com/en/contact-us . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. NTT DATA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click here . If you'd like more information on your EEO rights under the law, please click here . For Pay Transparency information, please click here .