108 Trackwise Jobs - Page 3

Description Regulatory Consultant Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities For non-complex and complex submissions, independently fulfill the following responsibilities: Demonstrated experience in authoring and review of Module 3 CMC sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities, according to current government regulations and guidelines Strong experience in assessing the change control issued by quality or regulatory department. Assess the regulatory impact of the change and develop submission strategy. Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions. Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions. Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies. Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle. Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems. Prepare estimates for conducting regulatory services as part of single or multiple service proposals. Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities. Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes. Prepare training materials and share best practices in the regulatory area, both internally and externally. Participate as regulatory support in internal or external project audits. Participate as regulatory support on internal cross-functional initiatives. Contribute to the creation and/or maintenance of SOPs and other process related documentation as required. Provide support in oversight to team members in the execution of their project responsibilities. Capable of identifying when to ensure line support required to provide additional guidance and direction. Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training. . Qualifications Minimum of 3 years in CMC post-approval variation renewals, annual reports, legal entity name changes, and other lifecycle maintenance activities. MS, M.Pharm or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory. Moderate pharmaceutical/medical device related experience. Demonstrated experience in contributing to the preparation of regulatory submissions including, for example post-approval CMC variations, IND, PMA, NDA, MAA, and CTD, including electronic submissions. Excellent interpersonal / communication skills including excellent written and verbal communication skills. Excellent customer service skills, with the ability to work both as a team member and independently. Good quality management skills. Advanced skills in Microsoft Office Applications. Strong experience in handling Veeva RIMS and TrackWise along with other RIMS systems, would be preferred. Ability to interact with staff from multiple departments and offices to establish project standards. Good initiative, adaptability, and pro-activity. Strong analytical skills, g ood attention to detail. Ability to work concurrently on projects, each with specific instructions that may differ from project to project. Fluent in speaking, writing, and reading English. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Company Description Epitome Components Ltd. is a leading PCB manufacturer in India with advanced infrastructure and a huge production capacity of 100,000 sqm/month. The company has a satisfied customer base throughout India and abroad, including leading Indian and MNCs such as Videocon, LG, Nokia, and others. Epitome has a joint venture with UK-based company Trackwise Designs Ltd. for manufacturing RF Antenna PCBs for high-end applications. Role Description This is a full-time on-site role for a Printing Engineer located in Ahmednagar. The Printing Engineer will be responsible for day-to-day tasks related to printing processes, quality control, and equipment maintenance in the production of PCBs. Qualifications BE/Dip Electrical/Electronics/Mechnical Ready to relocate Ahilyanagar (Ahmednagar Maharashtra) Proficiency in PCB printing processes and equipment maintenance Knowledge of quality control standards in PCB manufacturing Experience in troubleshooting printing issues and optimizing printing processes Strong analytical and problem-solving skills Attention to detail and accuracy in work Ability to work effectively in a team environment Prior experience in the electronics manufacturing industry is a plus Bachelor's degree in Electrical Engineering, Mechanical Engineering, or related field Show more Show less

Company Description Epitome Components Ltd. is a leading PCB manufacturer in India with advanced infrastructure and a huge production capacity of 100,000 sqm/month. The company has a satisfied customer base in India and abroad, including leading Indian and MNCs like Videocon, LG, Nokia, and others. Epitome also has a joint venture with UK-based company Trackwise Designs Ltd. for manufacturing RF Antenna PCBs for various high-end applications. Role Description This is a full-time on-site role for a Service Engineer located in Ahmednagar. The Service Engineer will be responsible for troubleshooting, field service, communication with clients, providing technical support, and maintenance & repair tasks on a day-to-day basis. Qualifications Troubleshooting and Maintenance & Repair skills Field Service and Technical Support abilities Strong communication skills Experience in electronics or PCB industry Knowledge of manufacturing processes and production equipment Ability to work independently and as part of a team Bachelor's degree in Engineering or related field Previous experience in a similar role is a plus Show more Show less

SAP Master Data Expert - 6 months - Contract - Full time - Remote - India We are seeking a meticulous and collaborative SAP Master Data Expert with functional business experience in SCM and MM to support enterprise-wide data transformation initiatives within the pharmaceutical sector. This role plays a critical part in ensuring the integrity, compliance, and readiness of master data—particularly in regulated domains such as manufacturing, quality, regulatory, and clinical systems. You will work closely with IT, regulatory affairs, quality assurance, and business stakeholders to ensure seamless data migration from legacy systems to validated platforms. Key Responsibilities Data Preparation & Governance Collaborate with IT and country-level Business Data Owners to identify in-scope data objects, including product, material, batch, and regulatory data. Maintain and govern master data lists for assigned objects, ensuring alignment with GxP and data integrity standards. Support the development of value mappings and data transformation rules in collaboration with technical teams. Provide domain-specific business insights to guide data extraction and conversion from legacy systems. Data Quality & Compliance Execute data cleansing activities in accordance with project timelines and regulatory expectations (e.g., ALCOA+ principles). Validate data quality throughout the migration lifecycle, ensuring compliance with internal SOPs and external regulatory requirements (e.g., FDA, EMA). Approve and execute data verification scripts to ensure completeness, consistency, and traceability. Data Migration & System Readiness Collect and prepare data for manual or construction-related objects, including those in manufacturing execution systems (MES), LIMS, or ERP platforms. Approve upload files pre- and post-load, ensuring formal documentation and audit readiness. Perform manual data entry and dual maintenance where required, particularly in validated systems. Hypercare & Issue Resolution Act as the Single Point of Contact (SPoC) for assigned data objects during Hypercare, supporting issue triage and resolution. Collaborate with QA and IT to manage data-related defects and ensure timely remediation in line with change control procedures. Key Performance Indicators (KPIs) Regulatory-Grade Data Cleansing : Completion of data cleansing activities in accordance with project timelines and compliance standards. Validated Data Loads : Successful and audit-ready data loads into GxP systems, aligned with migration schedules. Issue Resolution Efficiency : Timely resolution of data quality issues, with full documentation and traceability. Qualifications Experience in data migration or master data management within the pharmaceutical or life sciences industry. Expertise in Supply Chain Management(SCM) and Material Management/Master Modules(MM) within SAP in a Functional or Hands off capacity Familiarity with GxP, ALCOA+ principles, and regulatory data standards (e.g., IDMP, SPOR, ISO IDMP). Proficiency with data tools and validated systems (e.g., SAP, Veeva Vault, LIMS, TrackWise). Strong analytical, documentation, and stakeholder communication skills. Understanding of data governance frameworks and regulatory compliance requirements If you're available or have anyone in your network who could be suitable, please share your updated CV to mgordon@redglobal.com for immediate consideration Show more Show less

15+ years of experience in SAP transformation, development, and AMS projects with at least 3 End-to-End implementation projects Business Process Knowledge of topics viz. Quality Planning, Quality inspection, Quality Control, Quality certificates, Quality Notifications, Stability Studies, Batch Management etc. Experience of integrating SAP QM with External system 3PLs like MES, Trackwise, LIMS, Labware, Lab Vantage etc., and with other SAP modules, GXP and SOX requirements Experience as Solution Architect in the multiple programs of global scale Experience in Business Blue Printing, Design, Prototyping, Functional Analysis, Configuration, Gap Analysis, Conversion, Migration, Testing, Training, Cutover, Go-Live and Post Go-live Support activities, driving Business process workshops and Fit/GAP analysis Deep Knowledge and expertise in Quality Management BPML Good experience in Data migration process and ETL Tools Lead the engagement efforts at different stages from Problem definition to diagnosis to solution design, development & deployment, contribute to unit level & Organizational initiatives. Design, Build & Optimize End to End SAP Quality Management Processes for customers enterprise. Engagement Life cycle Management Client Opportunity Identification and Proposal Development Client Relationship Management Talent Management Marketing and branding using Thought Leadership Deal Influencing, Negotiation and Closure IP Creation and Management Knowledge Management SAP QM (Quality Management) with Pharma & Process Industry experience. The candidate is expected to be a senior Functional Architect for SAP Programs and will anchor the engagement effort for assignments, all the way from business process consulting and problem definition to solution design, development, and deployment for S/4HANA Quality Management. You will lead business transformation programs helping clients mitigate Digitization related challenges. You will be pivotal to problem definition and discovery of the overall solution and guide teams on project processes, deliverables. You will have the opportunity to shape value-adding consulting solutions that enable our clients to meet the changing needs of the global landscape. Domain experience in Quality Management with S/4HANA certification (preferred). Experience in Deal Pricing & Transformation Deal Estimations, Ability to work with different tools like, Solman, Doc Nav, Sharepoint, Mercury QC etc. Sufficient ABAP, Fiori, Technical know-how to co-ordinate better with technical teams. Should have experience of Change Management, Task Planning, Project Reporting, Resource Management, Process Improvement, Supervising. Show more Show less

YASH Technologies is a leading technology integrator specializing in helping clients reimagine operating models, enhance competitiveness, optimize costs, foster exceptional stakeholder experiences, and drive business transformation. At YASH, we’re a cluster of the brightest stars working with cutting-edge technologies. Our purpose is anchored in a single truth – bringing real positive changes in an increasingly virtual world and it drives us beyond generational gaps and disruptions of the future. We are looking forward to hire Trackwise Professionals in the following areas : Job Summary We are seeking a skilled and detail-oriented TrackWise Specialist to join our Quality Systems team. The ideal candidate will have hands-on experience with the TrackWise Quality Management System (QMS) and will be responsible for configuring, maintaining, and supporting TrackWise workflows and modules to ensure compliance with regulatory requirements and internal quality standards. Key Responsibilities Configure and maintain TrackWise workflows, forms, and reports. Collaborate with cross-functional teams to gather requirements and implement QMS solutions. Perform system administration tasks including user access management, troubleshooting, and upgrades. Support validation activities including IQ/OQ/PQ documentation and execution. Provide training and support to end-users on TrackWise functionalities. Ensure compliance with FDA, ISO, and other regulatory standards. Participate in audits and inspections as a TrackWise subject matter expert (SME). Required Skills 5+ years of experience working with TrackWise QMS (preferably versions 8 or higher). Strong understanding of quality processes such as CAPA, Deviations, Change Control, and Audits. Experience with system validation in a regulated environment (GxP, 21 CFR Part 11). Familiarity with SQL, Crystal Reports, or other reporting tools is a plus. Excellent problem-solving, communication, and documentation skills. At YASH, you are empowered to create a career that will take you to where you want to go while working in an inclusive team environment. We leverage career-oriented skilling models and optimize our collective intelligence aided with technology for continuous learning, unlearning, and relearning at a rapid pace and scale. Our Hyperlearning workplace is grounded upon four principles Flexible work arrangements, Free spirit, and emotional positivity Agile self-determination, trust, transparency, and open collaboration All Support needed for the realization of business goals, Stable employment with a great atmosphere and ethical corporate culture Show more Show less

Veeva Vault Quality Management System (QMS) Specialist Job Overview We are seeking a skilled Veeva Vault Quality Management System (QMS) Specialist, Aboobacker, to manage and optimize our Veeva Vault QMS platform. This role ensures seamless administration, configuration, and compliance of quality processes, collaborating with cross-functional teams to enhance operational efficiency and regulatory adherence in a life sciences environment. Key Responsibilities Serve as the primary administrator for Veeva Vault QMS, managing configuration, workflows, and triggers for quality processes such as audits, deviations, and supplier qualifications. Collaborate with business process owners to design and implement QMS workflows, ensuring alignment with regulatory requirements (e.g., FDA, EMA, GxP, and ICH guidelines). Support integration of Veeva Vault QMS with other systems (e.g., QualityDocs, RIM) using Vault Connections to streamline change control and data synchronization. Develop and maintain dashboards, reports, and metrics to monitor quality processes and ensure inspection readiness. Conduct system testing, validation, and change control assessments for new releases and enhancements, ensuring compliance with GAMP 5 standards. Provide end-user training and support, creating training materials and resolving technical issues to minimize downtime. Implement protocols for data integrity, backup, disaster recovery, and system security to ensure HIPAA and regulatory compliance. Proactively identify and resolve system issues, driving continuous improvement in quality management processes. Qualifications Bachelors degree in a related field (e.g., Life Sciences, Computer Science, or Engineering) with 5+ years of experience in quality management or system administration in a pharmaceutical or biotech environment. Proven expertise in Veeva Vault QMS administration, configuration, and workflow design. Strong knowledge of GxP, FDA, EMA regulations, ICH guidelines, and quality assurance/control operations. Experience with system validation (GAMP 5 Category 4) and regulatory audits. Excellent communication, problem-solving, and collaboration skills, with the ability to work in a team-based environment. Familiarity with Veeva Vault integrations (e.g., QualityDocs, RIM) and APIs is a plus. Preferred Skills Experience with Veeva Vault QualityDocs or Training modules. Knowledge of SQL, relational databases, or data analytics for reporting. Certification in Veeva Vault administration or quality management systems. *************************************************************************************************** Veeva Vault Learning Management System (LMS) Specialist Job Overview We are looking for a dedicated Veeva Vault Learning Management System (LMS) Specialist, Aboobacker, to oversee the administration and optimization of our Veeva Vault Training platform. This role manages training content, curricula, and compliance, ensuring role-based qualification and GxP readiness for life sciences professionals. Key Responsibilities Administer Veeva Vault Training, configuring training workflows, curricula, and assignments for documents, videos, eLearning, and on-the-job training. Collaborate with functional area heads to develop and approve training content, ensuring alignment with GxP job functions and regulatory requirements. Create and manage role-based training matrices, tracking qualification and compliance status via reports and dashboards. Integrate Veeva Vault Training with QualityDocs to automate re-training based on document changes and ensure seamless content access. Provide end-user training, develop training materials, and support users in navigating the LMS, resolving issues promptly. Conduct data integrity checks and prepare for regulatory audits, ensuring Part-11 compliance and inspection readiness. Support the implementation of new training modules, assess system updates for training impact, and manage change control processes. Maintain system security, user accounts, and data backup protocols to safeguard training data and ensure HIPAA compliance. Qualifications Bachelors degree in a related field (e.g., Life Sciences, Education Technology, or Computer Science) with 5+ years of experience in training management or LMS administration in a regulated industry. Expertise in Veeva Vault Training administration, configuration, and content management. Strong understanding of GxP training requirements, FDA Part-11, and regulatory compliance in life sciences. Experience with training matrix development and regulatory audit preparation. Excellent organizational, communication, and problem-solving skills. Familiarity with Veeva Vault integrations (e.g., QualityDocs) and eLearning standards (e.g., SCORM) is a plus. Preferred Skills Experience with Veeva Vault QMS or QualityDocs modules. Proficiency in data analytics for training compliance reporting. Certification in Veeva Vault administration or learning management systems. *************************************************************************************************** Veeva Vault Document Management System (DMS) Specialist Job Overview We are seeking a proficient Veeva Vault Document Management System (DMS) Specialist, Aboobacker, to manage and optimize our Veeva Vault QualityDocs platform. This role focuses on the administration, configuration, and compliance of document management processes, ensuring efficient document lifecycle management and regulatory adherence in a life sciences environment. Key Responsibilities Administer Veeva Vault QualityDocs, managing document types, lifecycles, workflows, and permissions to support controlled document processes. Collaborate with stakeholders to design and implement document management workflows, ensuring compliance with regulatory standards (e.g., FDA, EMA, GxP). Support integration of Veeva Vault QualityDocs with QMS and Training modules to enable seamless document access and automated processes. Develop and maintain document metadata, reports, and dashboards to track document status and ensure audit readiness. Perform system testing, validation, and change control for new features and releases, adhering to GAMP 5 standards. Provide end-user training and support, creating user guides and troubleshooting document management issues to minimize disruptions. Implement data backup, disaster recovery, and security protocols to protect sensitive documents and ensure HIPAA compliance. Drive continuous improvement by optimizing document workflows and resolving system performance issues. Qualifications Bachelor’s degree in a related field (e.g., Life Sciences, Information Systems, or Computer Science) with 5+ years of experience in document management or system administration in a regulated industry. Proven expertise in Veeva Vault QualityDocs administration, configuration, and document lifecycle management. Strong knowledge of GxP, FDA Part-11, and document control requirements in life sciences. Experience with system validation and regulatory audit preparation. Excellent communication, analytical, and collaboration skills, with a focus on detail-oriented process optimization. Familiarity with Veeva Vault integrations (e.g., QMS, Training) and metadata management is a plus. Preferred Skills Experience with Veeva Vault QMS or Training modules. Knowledge of document metadata standards and reporting tools. Certification in Veeva Vault administration or document management systems. Benefits (Applicable to All Roles) Competitive salary and comprehensive benefits package. Opportunities for professional growth, including Veeva certification programs. Flexible, remote-friendly work environment. Collaborative culture focused on innovation, compliance, and excellence in life sciences. Application Process To apply for any of these positions, please submit your resume and cover letter to [insert application email/link], specifying the role (QMS, LMS, or DMS Specialist) in the subject line. We look forward to welcoming Aboobacker or another qualified candidate to our team to drive excellence in Veeva Vault platform management.

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: Senior Manager - Production Date: Jun 2, 2025 Location: Mohali - Operations Company: Sun Pharmaceutical Industries Ltd Position: Sr.Manager Production (OSD) Job Title: Job Grade: G9A Function: Sun Global Operations Sub-function: Manager’s Job Title: Skip Level Manager’s Title: Function Head Title: Location: Mohali No. of Direct Reports (if any) Areas of Responsibility Planning of Production and Packing activities as per requirement to achieve the monthly targets To review the Production activities on daily basis for Granulation, Compression, Coating, Capsule filling, Inspection, Packing and Nutra section as per daily production plan (Plan Vs Actual) To ensure Good Documentation Practices (GDP) at shop floor and packing area. To coordinate with IPQA/QC/Engineering/PPC/SCM/EHS & FDD/MSTG department for smooth functioning of Production and Packing activities. Handling of SAP related work in Production. To ensure online documentation as per cGMP practice in Production area. Implementation of best practices on shop floor with respect to cGMP and to ensure that all activities of production and packing area are carried out in compliance with cGMP and safety guidelines. To review SOPs, user requirement specification (URS), purchase requisition (PR), Investigations, Process validation protocol/report, Equipment qualification protocol/report and other QMS documents. To handle the QMS activities in Trackwise /EDMS to review/approve the documents. To ensure timely and smooth execution of commercial validation batches. To ensure proper man power allocation and utilization in the Production/ Packing department. To impart and ensure on time training to officers and workers on cGMP, SOPs, GDP and EHS. To fill the daily assessment sheet as per the target assigned by the seniors. To involve in commercial product troubleshooting along with other departments to ensure timely delivery of product to market. To review technical protocols, reports related to investigational/ verification batches of approved products. To ensure that the products are produced and stored according to the appropriate documentation. To ensure on time implementation of corrective and preventive action (CAPA) with respect to investigation or audit findings or as and when required for compliance. To check the maintenance of the department, premises and equipment. Ensure timely review and implementation of master documents required for smooth production. To ensure timely preparation and review prerequisite documents required for execution of validation batches like BOMs, BMRs, protocols and reports etc. To ensure optimum capacity utilization, efficiency setting and productivity enhancement. Drives business excellence initiatives in production and packing area like Kaizen, Six sigma, 5S etc. To improve the production and packing process for less time, utility consumption and better quality. To report any deviation and abnormality of any type to seniors. To perform any other works as and when assigned by operation Head/Management. Travel Estimate Job Requirements Educational Qualification B.Pharm / M.Pharm Specific Certification Skills Experience 18 to 20 Yrs Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

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: Manager - Engineering (OSD) Date: May 16, 2025 Location: Paonta Sahib - Engineering Company: Sun Pharmaceutical Industries Ltd Role : Manager Engineering & Projects (OSD) Location : Poanta Exp - 14 to 15 Yrs Ensure compliance to cGMP and safety regulations. Ensure compliance to maintenance of process equipment as per SOP. Review and approval of all SOP’s related to process equipment’s. Approval and review of QMS (Deviation, CCR, CAPA) periodically. Create purchase requisition of the critical spare procurement and its inventory. Audit compliance of engineering documents and compliance of points observed from any regulatory as well as internal audit. Support to validation team for periodic validation of process equipment Initiation of deviation, change control, investigation and CAPA in Trackwise. Monthly review of KPI with respect to maintenance of process equipment and appropriate corrective and preventive action. Follow up for AMC services. Compliance and response to records of process equipment’s. Review of all cGMP records of Pharma maintenance. Ensure timely training completion of sub-ordinates. In-house projects, vendor coordination. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

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: Senior Executive Date: May 23, 2025 Location: Jammu - Operations Company: Sun Pharma Laboratories Ltd To ensure proper receipt of packing material & misc material after proper verification of documentation, preparation of GRN. To ensure proper verification and segregation of material before preparation of GRN. To ensure material is stored as per locator codes. To ensure proper issuance of packing material from production department. To ensure proper returns of issued packing material from production department. To ensure proper maintenance of documents and records. To prepare MDN's as per SOP as & when required. To ensure day to day records of humidity / tempreture/ performance of weighing scales is being carried out and recorded. To ensure proper handling of rejected material as per SOP. To ensure proper disposal of scrap as and when rquired. To ensure timely release of packing material for production. To generate requirement of packing material and place purchase requisition as per RFC. To follow Trackwise, EDMS for change controls and revision of SOP's as and when required. To maintain the records for calibration, validation of all the equipments installed in warehouse. To reconcile all packing materials as and when required and maintain proper locator codes. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

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: Executive Production Packing Supervisor Date: May 24, 2025 Location: Dewas SGO - Operations Block B Company: Sun Pharmaceutical Industries Ltd Role & Responsibility: To meet the production schedule both in quality and quantity. To maintain good discipline in the Packaging area and department. To ensure the implementation of EHS practices during the work To plan the activities of the area as per daily basis schedule To plan & allocate different jobs on daily basis to workmen/ machine operators of Secondary and primary Packing area. To check and verify the transfer of Primary Packing Material from P.M. staging to process area To ensure implementation of Good Packaging Practices and SOP during work. To maintain and improve quality of the products as per standard’s. To ensure the effective control on usage of men, machine and material in the department. To participate and co-ordinate various ongoing validation activities of equipment and system. To organize and implement the on-job training activities in the department. To supervise the Primary and Secondary Packing activities To ensure training completion of all employees working in secondary and primary area activities.. To conduct investigation of OOS, monitor CAPA and handle deviations. To ensure instruction of validation protocols, change controls, deviations, SOPs and specifications relating to production and ensure their strict implementations.. To maintain department and equipment in neat and tidy condition all the time. To control the rejection during secondary and primary packaging operations. To do counseling and grievance handling of the subordinates. To review the Batch Production Records after completion of the BPR. To perform any other related work allotted by the superior as per the production requirement. To work for the control of wastages during Packaging and to achieve higher yields of product. To perform all the trackwise and SAP related work. Any other responsibility to be completed that may be assigned for time to time. To perform investigation for Market Complaint and Deviations & handling of change controls. Completion of all the record work on daily basis Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

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: Manager - Corporate Quality Compliance (Compliants) Date: May 23, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Job Title: Manager Job Grade: M2 Function: Corporate Quality Compliance Sub-function: Complaints Manager’s Job Title: Senior Manager-1 Location: Vadodara Job Responsibilities Review of Product Quality Complaint Investigation Reports (US Market). Coordinate with other stakeholders involved in the complaint handling process. Monitor the progress of Filed Alert Reports, Recalls & Product Quality Complaint closure. Logging of Product Quality Complaints (PQC) in the database (TrackWise). Acknowledge the complaints to the complainants. Providing the response letter to the complainant. Reconciliation of received market complaints. Areas of Responsibility Product Quality Complaints Management Travel Estimate Approximately 10% Job Requirements Educational Qualification M.Sc (Life Sciences) / B.Pharm Specific Certification Nil Skills Good Technical & Communication Skills, Investigation writing, reviewing, and editing experience, candidate should have worked in USFDA work environment. Experience 13-14 years Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

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: Senior Manager - Corporate Quality Compliance Date: May 23, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Position: Senior Manager Sub-function: Global Actions Management Function: Corporate Quality Compliance Function Head Title: Sr. General Manager Location: Vadodara Areas of Responsibility Ensure assessment of Regulatory inspection citations identified at Sunpharma sites to derive the global action Ensure assessment of 483s, warning letter issued to other organization by USFDA to derive the global action Ensure assessment of internal learning (such as Quality alert) to derive the global action Preparation of Global action based, following are the sub-activities: v. Review of the regulatory guidance related to the topic vi. Review of existing site practices vii. Drafting of Global action recommendations viii. Preparation of reference procedures and associated formats for Global action implementation as applicable ix. Finalization of Global action recommendation post review with Global action committee and relevant stakeholders Ensure issuance and approving of Global actions in Trackwise. Coordinating with sites for the implementation of Global action recommendations Ensure review of site action closure for completeness and correctness Ensure closure of global action upon completion of all issued site action records of a global action Ensure circulation of Global action status to relevant stakeholders Ensure compliance calls being executed as per pre-defined agenda i.e. internal and external learnings being shared and explained with stakeholders. Ensure identified gaps being shared across sites and tracked for implementation Ensure maintenance of database for regulatory inspections at SUN Pharma Review of draft response of inspection observation Ensure Sun site regulatory inspection observations trend is in place for meaningful analysis All other duties as assigned by Head Corporate Quality Compliance and CQA Travel Estimate Approximate 30% Job Requirements Educational Qualification M.SC / M. Pharm Specific Certification Not specific Skills Quality Management System, Compliance, CAPA, Investigations, Audit Management, Supplier Qualification, Change Management, Manufacturing and Engineering Assurance (OSD and Sterile) Experience Minimum 15 years Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

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: Executive Date: May 26, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Position: Executive Job Title: Executive - CQC Job Grade: G12A Function: Corporate Quality Compliance Sub-function: Product Quality Complaints Manager’s Job Title: Senior Manager-1 Skip Level Manager’s Title: Head of Global Quality Systems Complaints Function Head Title: Linda Savage Location: R & D Tandalja, Vadodara No. of Direct Reports (if any) Nil Job Summary Logging of Product Quality Complaints (PQC) in the database (TrackWise). Acknowledge the complaints to the complainants. Follow up with the complainant for complaint sample and additional information to support Product Quality investigation. Providing the response letter to the complainant. Coordinate with other stakeholders involved in the complaint handling process. Reconciliation of received market complaints. Areas of Responsibility Product Quality Complaints log in management. Travel Estimate Less than 5% Job Scope Internal Interactions (within the organization) Yes External Interactions (outside the organization) Yes Geographical Scope India Financial Accountability (cost/revenue with exclusive authority) Nil Job Requirements Educational Qualification M.Sc / B.Pharm Specific Certification Nil. Skills Hands on experience in computer handling. Good Knowledge in MS Office. Fluency in English. Experience 0 to 3 years Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s). Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

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: Manager, Microbiology Date: May 9, 2025 Location: Dadra - Quality Control Company: Sun Pharmaceutical Industries Ltd Manager, Microbiology Location: Dadra Designation: Manager 2 Education: BSc / MSc in Microbiology Experience: 10+ Years Maintain the microbiology laboratory as per regulatory requirements. Planning and coordination with cross functional team for timely release of the RM,FP, Stability samples. Handling of microbiology related OOS/OOT, Deviation, Lab event. Prepare the response and closure of audit observations. Change control management for revision of SOP’s, Validation protocol. Ensure the availability of resources of microbiology laboratory. Ensure the microbiologist certification program of all microbiologist. Implementation of new projects for cost saving, compliance enhancement , work simplification. Having technical knowledge of following major test MLT of OSD products and MLT validation. Disinfectant efficacy test ( Disinfectant Validation) Maintenance of microbial cultures Maintenance of Microbiological media, Growth promotion test. Autoclave validation LAF, Biosafety cabinet, Incubators, pass box validation. Objectionability assessment of identified inhouse isolates. ALCOA++ Good knowledge of various guidelines like ISO14644, HTM 2010, EU Annex 1, 4, WHO, USP chapter 60, 61, 62, 1115, 1116, 1072, 21 CFR regulations Part 210, 211 Environment monitoring program design, risk evaluation, Location selection, Alert and action limit establishment. Purified water system validation. Chemical and microbial analysis of water. Audit experience for FDA, MHRA. ANVISA, TGA etc. Handling of software following but not limited: SLIMS, Lonza Moda, Equisoft, Vitek 2 compact software, High air flow, ICDAS, Trackwise, EDAMS, LMS, e residue , Lab X software, TOC software Hands on experience of major instruments like: Vitek 2 system, TOC analyser, Autoclave, Conductivity meter, Air sampler, Digital Microscope, LAF, Biosafety cabinet. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Preferred candidate profile Qualification : B Pharma/ M Pharma Experience : Min 3 years in QMS in OSD TrackWise Change control CAPA Deviation Others : Shift : General Female candidates are also eligible. Interested candidate may share resume at hr.plant@zuventus.com

Trending Job Description Provide remote analytical support to PPL sites, including review of analytical data and preparation of documents such as specifications, test methods, and protocols. Upload documents for review in ENSURE and initiate QMS elements in TrackWise/eDMS. Prepare and review stability protocols and reports, and perform stability data trending and analysis Responsibilities Review of analytical data generated in the analytical lab (QC/AS) including but not limited to Cleaning verification data, IPC, raw materials, intermediates, finished products, cleaning verification/validation, stability, and method validation data according to cGMP, GDP, in a timely manner. Review of reports for accuracy and completeness. Reports may include but not limited to: method validation reports, stability reports, lab equipment and instrumentation Calibration and Preventive Maintenance (PM) Reports, etc. Knowledge in analytical data review in Empower/Chromeleon/Open-Lab/Lab-Notebooks/LIMS/QMS module. Analytical Method Development and Documentation: Create and revise working test methods in compliance with compendia requirements and laboratory practices to support analytical testing. Change Request Forms (CRF) Management: Routinely initiate and manage Change Request Forms via the TrackWise system, including updates to product specifications and Certificates of Analysis (COA). Data Trending and Out-of-Trend (OOT) Analysis: Perform trend analysis of release testing data to identify OOT results. Develop, implement, and maintain procedures for trending and statistical data evaluation. External Data Review: Review analytical data generated by external laboratories to ensure compliance with specifications and quality standards. Share the review deficiencies with site team for further actions. Develop, revise, and review stability protocols and documentation in accordance with ICH guidelines and product-specific requirements, prepare stability summary reports with statistical analysis and trending to evaluate data and ensure regulatory compliance and data integrity. Conduct thorough Compendia reviews of USP (United States Pharmacopeia) monographs and ensure alignment with internal specifications and regulatory expectations. To participate and support site during customer audits and regulatory inspection. Lead and participate any other task assigned by HOD. Qualifications B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent Job Info Job Identification 8774 Posting Date 06/03/2025, 08:30 AM Apply Before 06/30/2025, 08:30 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 Show more Show less

Trending Job Description This role supports Quality Management System (QMS) activities including tracking and reviewing CRFs, CAPAs, deviations, and SOPs across multiple sites. Responsibilities include documentation control, data analysis, digital transition support, and coordination with site teams to ensure compliance with cGMP standards. The position also involves audit support, workflow optimization, and cross-functional collaboration to drive timely closure of quality events Responsibilities 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. Assist in the transition from physical to electronic forms (Leucine project). Support the review of manufacturing documentation (e.g., shipping/receiving logs, PM records). Collaborate on defining and improving document workflows and review processes. 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. Coordinate site review activities and ensure workflow efficiency. 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 8772 Posting Date 06/03/2025, 08:44 AM Apply Before 06/30/2025, 08:43 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 Show more Show less

Job Purpose: To ensure effective and timely management of product complaints by receiving, documenting, investigating, analyzing, and resolving product-related complaints in compliance with applicable regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, MDR). The role supports continuous improvement of product quality and customer satisfaction. Key Responsibilities: Receive and log product complaints from customers, sales team, or regulatory bodies in the complaint management system. Acknowledge receipt of complaints and communicate resolution timelines to complainants. Evaluate the complaint to determine if it qualifies as a reportable event per regulatory requirements. Coordinate with cross-functional teams (R&D, Quality, Manufacturing, etc.) to investigate root cause(s). Ensure timely and accurate completion of complaint investigations, CAPA initiation (if required), and closure within defined timelines. Document complaint details, investigation findings, corrective actions, and outcomes. Communicate findings and resolutions to stakeholders and customers. Generate monthly/quarterly complaint trend reports and risk assessments. Support external/internal audits and regulatory inspections by providing complaint-related documentation. Maintain compliance with company SOPs, ISO standards, and regulatory requirements. Recommend preventive actions and contribute to quality improvement initiatives. Required Qualifications and Skills: Bachelor’s degree in Pharmacy, Science, Biomedical Engineering, or equivalent field. 3+ years of experience in product complaint handling, preferably in the medical device or pharmaceutical industry. Knowledge of ISO 13485, FDA regulations, MDR, and other global regulatory requirements. Strong analytical, problem-solving, and documentation skills. Familiarity with complaint management software or QMS tools (e.g., TrackWise, MasterControl, etc.). Excellent communication skills – written and verbal. Attention to detail and a commitment to quality and compliance. Preferred Qualifications: Certification in Quality Management Systems or Regulatory Affairs. Experience in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA). Exposure to CAPA, NC, and audit handling processes. Show more Show less

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. 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 areas o IT QMS o Validation/Qualification o Risk management. o Handling of defects/Deviations o Investigations o CAPA Handling o Test 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. Show more Show less

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role Veeva’s Vault Quality suite is a single authoritative source, enabling greater visibility and control. Vault Quality enables organizations to modernize quality management, assuring quality while driving compliance and operational innovation. We are looking for Consultants with Life Sciences experience and a passion for helping customers optimize their quality data and document management operations in the cloud. What You'll Do Participate in projects at life sciences companies designing and deploying Quality systems Support Functional Analysts in workshops and be part of customer discussions of the Vault Quality suite (Vault QMS, Vault QualityDocs, Vault Training) Quality/Content management solution design, prototyping, configuration, and documentation Solution and configuration of Veeva Vault Quality Suite per customer requirements, including workflows, document types, security, fields, page layouts, reports, dashboards, formatted output reports, and notifications Leveraging enablement of out-of-the-box or best practices configuration approach to solution strategy Assessing the impact of change on the current configuration and working with key stakeholders to make informed decisions in a timely manner Represent Professional Services across multiple engagements and workstreams (e.g., solution design and configuration, data migration, systems integration, etc.) Ensure customer success from the beginning to the end of the engagement life cycle Requirements 4+ years of experience implementing Document or Quality Management systems for life sciences as a consultant, business, or IT representative Bachelor's Degree in Life science, computer science, or related degree Solid analytical and great interpersonal skills Excellent communication skills (written and verbal) Strong attention to detail Highly organized Ability to act with speed to understand business requirements and willingness to "roll up your sleeves" to design and implement a solution Exposure to life sciences compliance and computer systems validation requirements Nice to Have Understanding of global quality requirements, compliance considerations, and processes for Quality process and content management, life sciences compliance, and/or computer systems validation Proven track record leading high-impact global system implementation programs as a consultant, business, or IT lead, and/or business sponsor Direct experience with systems, such as Veeva Vault, ETQ Reliance, Sparta TrackWise, OpenText, SharePoint, Documentum D2, FirstDoc FirstPoint, NextDocs, UL ComplianceWire, and other quality information management or content management systems SaaS/Cloud experience Knowledge of Quality operations within the Life Sciences, Pharmaceutical, Biotech industry, and/or equivalent. Perks & Benefits Flexible PTO Health & wellness programs Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. Show more Show less

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 Show more Show less

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Vantive: A New Company Built on Our Legacy Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support. Job Summary Job Title – Research Associate III (Testing Coordinator) Location – Whitefield, Bangalore Shift – General This position is responsible for The Testing Coordinator will utilize his/her scientific knowledge to own operational excellence and continuous improvement; This role involves streamline processes; coordinate business, management, and technical SMEs; identify risks; devise solutions, all to support the establishment of Operational excellence. Essential Duties And Responsibilities Provide business and execution leadership for multiple analytical and stability-related projects and holding accountability for testing schedules, risks, and interacts with all functions and levels of management ensuring effective communications. Lead internal initiatives that enhance operational excellence. Interact with platform core team leaders and other key business stakeholders to be able to proactively anticipate business needs. Process inputs from Global Analytical, Stability Functional Leader and Analytical leads and Stability SMEs to determine schedules and forecast resource allocations to projects. Ensuring the availability of all prerequisites for scheduled laboratory analytical and stability testing. Master the planning of activities for testing and ensure on-time completion of all testing activities. Effectively coordinate testing with global teams and CROs as applicable to meet the KPIs on time. Interact with other testing groups (Particle, Sterility/BET, etc.) to determine schedules and alignment with business needs/function commitments. Ensure the maintenance of laboratory compliance as per regulatory requirements. Ensure import licenses are in place and manage laboratory samples inventory. Coordinate with procurement and technical teams for on-time procurement of chemicals and resolution of analytical instrument problems. Coordinate with external and internal sample shipment personnel’s for receiving testing samples on time. Participate in handling of laboratory investigations that correspond to atypical or out-of-specification/out-of-trend test results and other nonconformance records and leverage critical thinking skills to drive the investigation to conclusions based on sound scientific principles and propose appropriate corrective and Preventive root causes. Author/Follow SOPs of relevant procedures. Qualifications Proven experience in stability testing, analytical method validation and transfers, laboratory management, or a similar role. Strong leadership and project management skills. Excellent communication and interpersonal skills. In-depth knowledge of relevant QSRs, GxP, and other regulatory requirements. Handling of software like Trackwise. Proficiency in resource planning and inventory management. Critical thinking and problem-solving skills. Ability to work effectively in cross-functional and global teams. Proactive and able to anticipate business needs and challenges. Basic computer skills (MS Office Word, Excel, PowerPoint, etc.) Education: Master’s in chemistry or Pharmaceuticals, with 6 to 10 years of experience. Education And/or Experience Bachelor’s degree with 8-14 years’ or Master’s degree with 5 to 10 years' of experience in relevant scientific discipline (Analytical chemistry/Pharmaceutical chemistry). Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. Show more Show less

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us. Your Role Work as a team to support Process Solutions organization of Company’s LS to achieve the goal. Process service complaints in Trackwise and ERP. Hands on experience in ERP system SAP, Oracle and CRM tool SFDC. Knowledge of order management process and the concept of creating debit & credit. Partner with team to deliver quality services, enhance operational efficiencies. Process customer documentation requests and Process Leads in SFDC. Contribute to incremental revenue directly or indirectly. Complaint management – Handling service complaints. Create & assign Leads for Sales and Marketing team by critical thinking. Create orders in ERP/other tools for credit, debit, investigation and return and establish the strong follow ups with key partners to close the requests in SFDC. Coordinating with Customer master data team to update customer masters. Process on discrepancy area database request and quality task request in ERP system. Review of errors done by team and giving suggestion to mitigate the future occurrence. Build robust relationship with key partners and stakeholders. Who You Are Any Bachelor’s Degree from recognized university. Preferably with relevant experience in SFDC, SAP. Experience in Order Management / Service Complaints with 1-2 experience is preferred. Should possess basic knowledge of SFDC Functional Knowledge and ERP (SAP& Oracle) User Knowledge. Hands-on experience on ERP’s like SAP, SFDC. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team! Show more Show less

India - Hyderabad JOB ID: R-214289 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Apr. 29, 2025 CATEGORY: Quality Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let’s do this. Let’s change the world. In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities. Responsibilities Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Serve as Owner or QA Contact for handling the Deviations. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will be required to go into the office as dictated by the site policy. Validation Validation Documentation: Review and approve all validation documentation, ensuring compliance with regulatory requirements and internal quality standards. Requirement Specifications & Test Protocols: Review and approve Requirement Specifications, Design Specifications, Test Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices. System Life Cycle Documents: Review and approve System Life Cycle Documents (e.g., test protocols) prior to their use in production. Data Integrity Assessments: Review and approve Data Integrity Assessments to ensure data is accurate and complies with regulatory standards. Change Control Management: Initiate, review, and approve Change Control requests, acting as the QA contact for changes in systems (e.g Trackwise/Veeva , ServiceNow) Periodic Review/Audit Trail System Periodic Reviews & Audit Trails: Review and approve periodic system reviews and audit trail reports to ensure system integrity and compliance. Supplier Management Supplier Evaluations : Provide support for supplier evaluations as needed, ensuring suppliers meet quality, compliance, and performance standards. Deviation & CAPA Management: Initiate and manage deviations (major and minor) as required. Serve as the primary QA contact for deviations, ensuring proper investigation and resolution. Act as the quality reviewer and approve for problem records in ServiceNow, ensuring that all records meet internal quality standards. CAPA & Effectiveness Verification (EV): Serve as the QA contact or owner for Corrective and Preventive Actions (CAPA) and Effectiveness Verification (EV) records, ensuring timely and effective resolution. Responsible as a Business Owner for overseeing and managing specific GxP Computerized Systems programs and projects, ensuring compliance with regulatory standards and alignment with business objectives. Independently develop solutions that are thorough, practical and consistent with functional objectives. Review and approve operational and administrative Standard Operating Procedures (SOPs) and Work Instructions, ensuring alignment with regulatory and quality standards. Apply analytical skills to evaluate complex problems, utilizing both qualitative and quantitative data, including trend analysis, to develop effective solutions. Contributes to continuous improvement efforts and initiatives. Assists with training initiatives and strategy as required. Provides support for the Management Review Process when needed. Supports the Integrated Systems Assessment (ISA) Process as necessary. Participates in and aids with regulatory inspections as required. What we expect from you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with a minimum of 7 years experience in Software and Systems Quality assurance OR Bachelor’s degree with a minimum of 10 years of Software and Systems Quality assurance experience Preferred Qualifications: Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards. Proven experience in the validation of computerized systems and strong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP). Experience managing quality assurance processes, including Change controls, Deviations, CAPAs and effectiveness checks. Demonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills. Strong decision-making abilities with the capacity to drive tasks to completion. Ability to work independently with minimal supervision. Leadership skills with experience leading projects, teams, or tasks. Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems, LIMS, SAP and Maximo. Broad technical expertise within specialty area and familiarity with industry standards. Ability to provide training, guidance, and contribute to team quality. Works closely with leadership / senior staff and external experts to extend capabilities and enhance performance. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.