701 Capa Jobs

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in CSV and excellent leadership skills. Roles and Responsibility Lead the development and implementation of CSV strategies to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to identify and mitigate risks associated with CSV. Develop and maintain relationships with key stakeholders, including regulators and industry partners. Provide training and guidance on CSV best practices to team members. Conduct audits and assessments to ensure adherence to CSV standards. Develop and implement process improvements to enhance CSV efficiency and effectiveness. Job Requirements Strong knowledge of CSV principles and regulations, including FDA guidelines. Excellent leadership and communication skills, with the ability to motivate and guide team members. Experience working in a fast-paced environment with multiple priorities and deadlines. Strong analytical and problem-solving skills, with attention to detail and the ability to identify risks. Ability to work collaboratively with cross-functional teams, including sales, marketing, and engineering. Strong understanding of quality management systems and ISO standards. Location- Bengaluru,Chandigarh,Dadra & Nagar Haveli,Daman,Diu,Goa,Haveli, Jammu, Lakshadweep, Nagar,New Delhi,Puducherry,Sikkim

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for any graduation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Immediate Openings on CSV Analyst _Bangalore Experience : 5+ Skill:- CSV Analyst Location : Bangalore Notice Period :- Immediate . Employment Type: Contract . Job Description: Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAMP5, 21CFR Part 11, and good documentation practices - Knowledge on HP ALM and Jira Tool and validation approval process using ALM

1. To study and understand the project quality and documentation requirements from the project brief with the help of the project design team. 2. To prepare the project and quality plan for all the ongoing projects. 3. To prepare the document list based on the project scope, project timeline, and quality plan, including internal and vendor-provided documents. 4. To inform all relevant departments about the documentation and quality requirements. 5. To collect, prepare, review, modify, and approve documents related to procurement, installation, commissioning, qualification, validation, and handover using standard tools and software. 6. To track all documents for availability, correctness, and approvals from the project team, concerned departments, and clients. 7. To prepare critical qualification and validation document requirement specifications (URS), validation master plan (VMP), project and quality plan, impact analysis, corrective action and preventive action (CAPA), standard operating procedures (SOPs), risk analysis, etc. 8. To prepare and update standard templates for design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), handover forms, installation protocols, commissioning protocols, etc. 9. To maintain the document history and change logs throughout the project life. 10.To verify the documents and drawings for numbering, formats, signature panels, approvals, etc. 11.To coordinate with the client for document approvals, maintain records, and confirm receipt and version control. 12.To follow up on all site activities documentation related to installation, commissioning, qualification, validation, and handover. To perform the site as required If needed, visit the. 13.To track and send protocols to the site as per testing and reporting needs. Supervisory Role: 1. To prepare a work plan and work hour list for all new projects within the heating, ventilation, and air conditioning (HVAC) department. 2. To regularly update the plan and work hour list and get the same approved by the project team and superiors. 3. To allocate workload to team members as per project needs and deadlines. 4. To coordinate with the project management department team on client queries and documentation timelines. 5. To review and approve the workload and deliverables of subordinates for accurate submission of documents required for purchases, client approvals, construction at sites, etc. 6. To ensure that all the department reports are updated on a timely basis. 7. To ensure that all the documents, internal and external, are accurately organized in the data management system (DMS) as per the project requirements and plan. Requirements Skills and Competencies: 1. Good understanding of the basic concepts of HVAC, clean room construction, clean room flooring, piping, utilities, production equipment, and electrical systems. 2. Fluent in written and spoken English and Hindi. 3. Self-motivated and target-oriented. 4. Capable of drafting SOPs and templates aligned with GMP and regulatory requirements. 5. Strong analytical and logical reasoning skills. 6. Competent with spreadsheets and document tracking tools. 7. Ability to perform under pressure and meet strict deadlines. 8. High accuracy in documentation and effective time management. Knowledge: 1. Knowledge of the pharmaceutical industry in general, dosage forms in the formulation industry, and various equipment and systems that go into the operation and construction of a facility. 2. Knowledge of the latest Food and Drug Administration (FDA) and international good manufacturing practice (GMP) documentation standards. 3. Good knowledge of qualification and validation documentation for a pharmaceutical facility. 4. Attending and representing the company in GMP audits, inspections by FDA agencies, and practical validation on the production floor would be an added advantage.

Pre-preparation for Customer Key Handover as per SOP. Generate rapport with the customers coming for Key Handover Demonstrate a high degree of warmth while dealing with / talking to the customers Register all customer feedback/concerns and channelize it as per SOP in order to close the loop. Maintain Customer data confidentiality. Any other activity associated with Customer Engagements/ Events - assist in these

Lodha Group is looking for Data Analyst (Pre-Sales) to join our dynamic team and embark on a rewarding career journey Managing master data, including creation, updates, and deletion. Managing users and user roles. Provide quality assurance of imported data, working with quality assurance analysts if necessary. Commissioning and decommissioning of data sets. Processing confidential data and information according to guidelines. Helping develop reports and analysis. Managing and designing the reporting environment, including data sources, security, and metadata. Supporting the data warehouse in identifying and revising reporting requirements. Supporting initiatives for data integrity and normalization. Assessing tests and implementing new or upgraded software and assisting with strategic decisions on new systems. Generating reports from single or multiple systems. Troubleshooting the reporting database environment and reports. Evaluating changes and updates to source production systems. Training end-users on new reports and dashboards. Providing technical expertise in data storage structures, data mining, and data cleansing.

Develops, establishes and maintains quality engineering methodologies, systems,practices which meet BSC,customer,regulatory requirements. Serves as a Quality representative to improve awareness,visibility,communication on quality initiatives Required Candidate profile Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.

As a QA Assistant Manager with 5-7 years of experience in the pharmaceutical industry, you will be responsible for running the department independently. Your role will require strong skills in inter and intra-departmental communication, a desire to learn, and the ability to adapt and adopt to people and systems effectively. This position is based in Mumbai. Your key responsibilities will include: - Skilled handling of FDA-GMP audits to ensure compliance with regulatory standards. - Experience in establishing robust Quality Management Systems (QMS) to ensure compliance with GLP and cGMP standards. - Expertise in creating, reviewing, and maintaining Standard Operating Procedures (SOPs). - Managing and implementing change control processes effectively. - Proficient in preparing and maintaining Site Master Files, Master Validation Plans, and Batch Manufacturing Records (BMRs). - Conducting stability studies, managing stability programs, and handling Out of Trend (OOT) and Out of Specification (OOS) results. - Establishing and maintaining standards according to current regulatory guidelines and Pharmacopeia revisions. - Evaluating deviations, managing change controls, and implementing corrective and preventive actions (CAPA). - Proficient in equipment qualification, process validation, cleaning validation, and method validation. - Overseeing the calibration of equipment and adhering to ICHQ7A guidelines and other regulatory standards. - Conducting trend analysis, providing feedback for continuous improvement, and implementing Quality Risk Management strategies. - Working towards continuous improvement of quality systems and efficiently managing Quality Control departments. - Handling ISO documentation procedures, including quality manuals, work instructions, checklists, and audits. - Managing sampling and testing of excipients, Essential Oils, and Aroma chemicals. - Strong skills in effective manpower handling and communication in English, both oral and written. This is a full-time position with benefits including Provident Fund. The work schedule is day shift, and the work location is in person.,

You are invited to a Walk-In Interview at Zydus Corporate Park in Ahmedabad on Saturday, 28th June 2025, from 10:00 AM to 03:30 PM. Zydus is a global healthcare provider focused on innovation and committed to enhancing healthcare therapies to create healthier communities worldwide. ### SAP S/4 HANA Opportunities: 1. **SAP FICO Consultant:** - **Experience:** Minimum 5 years in SAP FI, FM, PS, CO, and S/4HANA. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Responsible for designing and implementing SAP FI/FM solutions, integrating with MM, SD, and PPQM modules, and driving process improvements. 2. **SAP ABAP Developer:** - **Experience:** Minimum 5 years in OOABAP, SmartForms, IDocs, and SAP HANA. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Design, develop, and optimize ABAP programs supporting SAP applications. 3. **SAP MM/WM Consultant:** - **Experience:** 5 - 8 years with S/4HANA, knowledge of warehouse management is advantageous. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Drive SAP MM implementations and integrations with SD, PP, QM, WM, and FI modules. 4. **SAP BW Consultant:** - **Experience:** 5 years. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Expertise in SAP BW and BO, strong development and maintenance skills, knowledge about SAP Process, and excellent communication skills. ### Microsoft Technology Opportunities: 1. **Full Stack Developer (Dotnet + Angular):** - **Experience:** 5-7 years with Azure DevOps, AKS, and Microsoft SQL Server. - **Education:** BE/BTech/MCA in IT/Computer. - **Location:** Ahmedabad. - **Profile:** Design and develop scalable solutions using .NET Core, Angular, and MS SQL. 2. **Dotnet Developer / ASP.NET Developer:** - **Experience:** 5-8 years with .NET Framework, IIS, WCF, and MS SQL Server. - **Education:** BE/BTech/MCA in IT/Computer. - **Location:** Ahmedabad. - **Profile:** Design and develop robust solutions using ASP.NET WebForms, MVC, and Core technologies. 3. **Sharepoint Developer:** - **Experience:** 6-12 years with Office 365, remote event receivers, and SharePoint migrations (2010-2016). - **Education:** BE/BTech/MCA in IT/Computer. - **Location:** Ahmedabad. - **Profile:** Design and develop solutions using SharePoint Online, SPFx, React, PowerApps, and Power Automate. ### Infrastructure & Compliance: 1. **IT CSV (Computer System Validation):** - **Experience:** 3-5 years. - **Education:** BE/BTech/MCA in IT/Computer. - **Location:** Ahmedabad. - **Profile:** Role involves 24x7 user access management, maintaining Privilege and User Access Matrices, handling IT QMS activities, supporting software assessments, network maintenance, conducting risk-based failure tests, and representing IT processes during audits and regulatory inspections. This walk-in interview is for experienced professionals. Freshers are encouraged to apply online for future opportunities. Priority will be given to candidates who can join immediately and are willing to relocate to the job location. For more information about Zydus, visit [Zydus Website](https://www.zyduslife.com/zyduslife/).,

The Quality Assurance Manager role at our organization in Bagru, Rajasthan requires a minimum of 5-7 years of experience and a Bachelors Degree (or higher) in Chemistry, Biochemistry, Food Science/Technology, Analytical Chemistry, Chemical Engineering, or related disciplines. As the Quality Assurance Manager, you will be responsible for ensuring that the lab's Quality Management System (QMS) complies with ISO/IEC 17025:2017 and other regulatory requirements. This will involve managing audits, maintaining lab safety and equipment, resolving customer complaints, and driving continuous improvement. Key responsibilities include implementing and maintaining ISO/IEC 17025:2017 QMS, managing client and regulatory audits, overseeing lab operations, safety, equipment, and records, reviewing and approving deviations, change controls, and CAPA, resolving customer complaints, and providing training on ISO/IEC 17025:2017 and quality practices. Additionally, the role requires conducting performance reviews, monitoring quality tools, and ensuring GLP compliance. To qualify for this position, you must have a Bachelors Degree (or higher) in a relevant field, 5-7 years of experience in quality assurance within a lab, strong knowledge of ISO/IEC 17025:2017 and GLP, excellent leadership, communication, and decision-making skills, as well as experience with audits, CAPA, and safety procedures. If you meet these qualifications and are ready to take on a challenging role in maintaining quality standards and compliance, we encourage you to apply for the Quality Assurance Manager position.,

This is an excellent opportunity at HCLTech for healthcare professionals with 2 to 3 years of experience in Quality (RCM and Denial Management). The role of Quality Analyst involves responsibilities such as daily quality review of transactions and calls, overseeing quality assurance and improvement, recommending and implementing quality improvement programs, enhancing process improvement, customer experience, and ensuring high-performing operation. This position requires working at night shifts and from the office for 5 days a week. The essential responsibilities of this role include achieving daily QA targets, reviewing and assessing transactions and calls, providing fair and objective feedback, reporting findings to agents and leads for training and improvement, collaborating on quality processes and scoring techniques, raising and resolving QA concerns promptly, coaching and providing feedback to monitored personnel and supervisors, identifying quality improvement opportunities, calibrating scores objectively, ensuring consistency across sites and teams, analyzing quality data, preparing QA reports, and working with leads and training team to address areas for improvement from QA results. The required skills and competencies for this position include providing regular coaching and feedback to agents, motivating employees for better results, strong communication and listening skills, coaching for performance improvement, knowledge about the US Healthcare industry, understanding healthcare provider business policies and practices, advanced interpersonal, presentation, and communication skills, effective problem-solving, decision-making, innovative thinking, and proficiency in Microsoft Office. Formal education and experience needed for this role include graduation in any stream, experience in denial management and calling, and 1-2 years of experience as a full-time quality analyst in US Healthcare. If you have the relevant experience in Quality - RCA, CAPA, Quality Tools, Agent feedback, and coaching in RCM & Denial Management, and meet the education and experience requirements, you can share your resume to maithreyee.a@hcltech.com for consideration. The mode of interview will be Virtual/Online.,

Function:PMSRole:Post Market SurveillanceDesired Skills:PMS, complaint handlingCreate PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis Risk management Risk assessment. Required Candidate profile Propose strategies and solutions to data issues or challenges that occur during the PSUR writing and conclusion process.

Job Specification: Must have worked with an IT Services Organization Technical background (BTech, BE, BCA, MCA, MTQM) In-depth knowledge of Software Engineering, Project Management Lifecycles, Agile Scrum, Kanban, DevOPS, Continuous improvement and QA lifecycles Understanding of tools such as JIRA, Service now, TFS, Microsoft Project, VSS, Sonar cube, Fisheye, Jenkins, and all Office Tools Appreciation of new GenAI models and their applicability on software projects, impact on productivity, process changes due to the new techniques etc. Should have knowledge of software process implementation, Audits, Metrics and in identifying improvements Strong analytical skills and knowledge on Root Cause Analysis techniques such as Fish Bone etc. Knowledge on statistical techniques for process improvement Thorough knowledge of CMMI, ISO 9K Experience process definition of Quality Management System/ process databases Strong facilitation skills for driving quality and innovation in projects High inter-personal skills Strong communication skills (Written, Verbal, Presentation skills, Assertiveness) Strong negotiation, problem-solving skills Responsibilities: Ensure an environment of Zero surprises by identifying risks by: Ensuring the project setup is done considering all risks and Facilitating projects by propagating best practices, guiding teams on engineering practices, analysis project data, status reports etc. Conducting in-depth engineering reviews, Milestone reviews, Defect data analysis, Project plan reviews, CAPA reviews Mentor PMs for identifying risks, data analysis, innovations etc. Participate in senior management review of projects Conduct SQA reviews and ensure process compliance in projects Analyse findings from SQA reviews and identify improvement themes Highlight the risks to the management at the right time and with all the facts Use the escalation matrix to highlight the risks to Delivery head as and when needed in a timely manner Review write assigned processes Change Requests Participate in innovation program as Innovation facilitators for delivery and enabling function Follow up with projects to ensure closure of action items of CSAT, Escalations/Complaints Participate in Project team meetings Facilitate and participate in projects Root Cause Analysis meetings Ensure formal Configuration Management of QMS documents and other documents Ensure best practices are captured and shared in organization Work closely with project managers, account managers, delivery leadership to understand the expectations and deliver outcomes Articulate contractual risks and work with senior management to mitigate the same Mandatory Competencies Beh - Communication and collaboration Business Assurance - Business Assurance

Manage electronic document control and version control on all project-related documents.Ensure adherence to the quality systems, design assurance SOPs, and Boston Scientifics PLCP. Required Candidate profile Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts (if required) for commercial products.

1. Factory & Warehouse Hygiene and Pest Control Ensure strict implementation of hygiene and sanitation protocols across the factory and warehouse. Oversee pest control measures and maintain compliance with food safety standards. Monitor and verify routine cleaning and deep cleaning (ALC) schedules in production and packaging areas. 2. Production & Packaging Quality Assurance Ensure adherence to quality parameters throughout the production and packaging processes. Conduct regular verification of quality control checks, including for online processes, gifting, and customized orders. Monitor CCP and OPRP to ensure process safety and consistency. 3. Material Verification & Warehouse Monitoring Monitor warehouse operations to ensure material storage, handling, and FIFO compliance. Perform Pre-Dispatch Inspections and ensure timely clearance of on-hold materials. Oversee Raw & packaging material checks and verify. 4. Laboratory Operations & Product Testing Supervise the preparation and use of chemicals for testing purposes. Conduct and validate physical, chemical, and shelf-life testing as per defined protocols. Coordinate with external laboratories for product and environmental testing (e.g., NI samples, water, air, swab, FSSR). 5. Training, Audits & Documentation Conduct internal training on personal hygiene, GMP, GHP, food safety, etc... and documentation practices. Prepare and maintain comprehensive quality documentation, including in-process, laboratory, and shift records. Lead internal and external audits in alignment with FSSC 22000 and BRCGS standards. Ensure timely closure of audit non-conformities and implementation of CAPA. 6. Regulatory & Interdepartmental Coordination Liaise with cross-functional teams to resolve quality-related issues effectively and promptly. Ensure compliance with applicable statutory and regulatory food safety requirements. Address customer quality complaints and drive root cause analysis and CAPA implementation. 7. Personnel Hygiene & Compliance Monitoring Ensure strict monitoring of personal hygiene practices across all staff and production areas. Validate and monitor hygiene compliance through regular audits. 8. Calibration & Equipment Validation Ensure timely calibration and maintenance of all quality and lab equipment. Maintain calibration records and ensure accuracy of instruments used in quality & production assessments. 9. Labelling & Artwork Compliance Ensure all product labels comply with FSSAI regulations (Nutritional information, Ingredients, Allergen Declaration etc...) and other applicable statutory guidelines. Review packaging designs and artwork for accuracy, legal compliance, and brand consistency. Coordinate with internal teams (Regulatory, Marketing, R&D) and external design agencies to finalize artworks. Ensure timely approval and closure of artworks to avoid production delays. Conduct online verification of labelling elements such as batch coding, MRP, expiry date, ingredient declaration, and allergen statements during production.

Job Specification: Must have worked with an IT Services Organization Technical background (BTech, BE, BCA, MCA, MTQM) In-depth knowledge of Software Engineering, Project Management Lifecycles, Agile Scrum, Kanban, DevOPS, Continuous improvement and QA lifecycles Understanding of tools such as JIRA, Service now, TFS, Microsoft Project, VSS, Sonar cube, Fisheye, Jenkins, and all Office Tools Appreciation of new GenAI models and their applicability on software projects, impact on productivity, process changes due to the new techniques etc. Should have knowledge of software process implementation, Audits, Metrics and in identifying improvements Strong analytical skills and knowledge on Root Cause Analysis techniques such as Fish Bone etc. Knowledge on statistical techniques for process improvement Thorough knowledge of CMMI, ISO 9K Experience process definition of Quality Management System/ process databases Strong facilitation skills for driving quality and innovation in projects High inter-personal skills Strong communication skills (Written, Verbal, Presentation skills, Assertiveness) Strong negotiation, problem-solving skills Responsibilities: Ensure an environment of Zero surprises by identifying risks by: Ensuring the project setup is done considering all risks and Facilitating projects by propagating best practices, guiding teams on engineering practices, analysis project data, status reports etc. Conducting in-depth engineering reviews, Milestone reviews, Defect data analysis, Project plan reviews, CAPA reviews Mentor PMs for identifying risks, data analysis, innovations etc. Participate in senior management review of projects Conduct SQA reviews and ensure process compliance in projects Analyse findings from SQA reviews and identify improvement themes Highlight the risks to the management at the right time and with all the facts Use the escalation matrix to highlight the risks to Delivery head as and when needed in a timely manner Review write assigned processes Change Requests Participate in innovation program as Innovation facilitators for delivery and enabling function Follow up with projects to ensure closure of action items of CSAT, Escalations/Complaints Participate in Project team meetings Facilitate and participate in projects Root Cause Analysis meetings Ensure formal Configuration Management of QMS documents and other documents Ensure best practices are captured and shared in organization Work closely with project managers, account managers, delivery leadership to understand the expectations and deliver outcomes Articulate contractual risks and work with senior management to mitigate the same Mandatory Competencies Beh - Communication and collaboration Business Assurance - Business Assurance

Performing audits of all Dr. Reddy’s Laboratories manufacturing, packing, testing, development centers and distribution warehouses as per the audit schedule. Primarily performing internal audits of CTO, FTO and R&D Sites. Performing GAP assessment of the new/revised regulatory guidance documents, USFDA warning letters / form 483s to evaluate the current approved documents for compliance / improvements or requirement of new procedures and harmonizing and implementing the best practices across sites. Review of audit responses and tracking the CAPA generated out of internal audits, regulatory audits, customer audits, cross-applicable CAPAs through OCMS, Warning letters & 483 forms gap assessment of all sites for timely and effective implementation. Performing on site verification or review of the documented evidence for compliance of previous audit observations. Preparation and review of harmonized Standard Operating Procedures and Guidance documents which shall be implemented at Global, FTOs, CTOs business units and related supporting functions. Assessing the impact on the procedures during implementation of changes in IT applications. Overview harmonization of CSV/IT compliance practices across Dr Reddy’s sites. Ensuring timely assessment and implementation of pharmacopeia and regulatory guidance updates w.r.t. CSV/IT compliance procedures across Dr Reddy’s sites. Ensuring review and implementation of simplification procedure for different CSV/IT compliance procedures across Dr Reddy’s sites to reduce redundancy. Tracking and revision of SOPs identified during SuCCEED drive and Re-Imagine QMS. Conducting training sessions for the approved documents before implementation of the procedure. Preparation of questionnaire for SOP in order to evaluate the effectiveness of training imparted. Initiation and review of quality notifications raised for revision, preparation of documents as per identified requirements. Timely communication to stakeholders about revision/implementation of SOPs. Providing data for monthly report. Providing support to sites during regulatory audits for review of systems / documents. Any work assigned by the Lead and Head of the Department Qualification M.Sc (Chemistry) with 15+ years of Pharma experience in IT/CSV quality Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com

About Company Founded in 2011, ReNew, is one of the largest renewable energy companies globally, with a leadership position in India. Listed on Nasdaq under the ticker RNW, ReNew develops, builds, owns, and operates utility-scale wind energy projects, utility-scale solar energy projects, utility-scale firm power projects, and distributed solar energy projects. In addition to being a major independent power producer in India, ReNew is evolving to become an end-to-end decarbonization partner providing solutions in a just and inclusive manner in the areas of clean energy, green hydrogen, value-added energy offerings through digitalisation, storage, and carbon markets that increasingly are integral to addressing climate change. With a total capacity of more than 13.4 GW (including projects in pipeline), ReNew’s solar and wind energy projects are spread across 150+ sites, with a presence spanning 18 states in India, contributing to 1.9 % of India’s power capacity. Consequently, this has helped to avoid 0.5% of India’s total carbon emissions and 1.1% India’s total power sector emissions. In the over 10 years of its operation, ReNew has generated almost 1.3 lakh jobs, directly and indirectly. ReNew has achieved market leadership in the Indian renewable energy industry against the backdrop of the Government of India’s policies to promote growth of this sector. ReNew’s current group of stockholders contains several marquee investors including CPP Investments, Abu Dhabi Investment Authority, Goldman Sachs, GEF SACEF and JERA. Its mission is to play a pivotal role in meeting India’s growing energy needs in an efficient, sustainable, and socially responsible manner. ReNew stands committed to providing clean, safe, affordable, and sustainable energy for all and has been at the forefront of leading climate action in India. WTG Auditor- for AHA Job Purpose : “To Improve Reliability & Maintain High Quality Standards for Life Cycle Asset Management by” Identifying technical issues, trouble spots, pre-detection of risks & unseen snags. Effectiveness of maintenance done. Using Innovative techniques, Artificial Intelligence & Machine Learning Monitoring & Reviewing Effectiveness of RCA & Corrective & Preventive actions (CAPA) implementation. Roles and Responsibilities : Wiling to travel across all the sites. Expertise in WTG operation & maintenance process. Expertise in WTG troubleshooting (Electrical, Mechanical, Other components). Knowledge of WTG component functioning. To perform quality assurance & vigilance checks on WTGs. To perform special tasks, retrofits, investigate risks associated with assets. To perform SCADA data desktop study & knowledge on OEMs software tools. To check documentation as per ISO & Quality standards. To perform report on observations. Proficient with MS Office (word, excel, power point) Inspection to be done in totality irrespective of different WTG parts. To perform tasks as per safety standards. Educate concerned AM team members Deliverables : The quality of the turbine is as per specs. Review of all compliance assessment reports provided by the original equipment manufacturer. Focus on the performance parameters and operational life of the asset and maintaining safe work practices at site. Inspection carried out to identify compliances with defined parameters site specific and mitigate the non-compliances. Specific inspections of the prime components and their peculiarities Assessment of EHV lines healthiness through advanced technologies. Performance compliance assessment with advance innovative technologies / tools for healthiness & pre detection of risks. Holistic view of inspection to be done to identify the risks. Audit Reports will be produced for each WTG / e-BoP / wind farm. Profile & Eligible Criteria : Education: B.E / B.Tech in Electrical 3 to 5 years of experience required Worked on WTG Main Interfaces : OEM Technology teams Technical Consultants ReNew Power – Engineering & Asset Management teams

As a Manager-II in the MSTG department at Sun Pharmaceutical Industries Ltd, your primary responsibility will be to provide support for the execution and monitoring of trial, scale up, exhibit process qualification batches. You will be involved in preparing and reviewing new product documents such as material requirement sheet, master formula card, bill of material, master formula, risk assessment reports, sampling protocol, reports, exhibit batch manufacturing record, and exhibit protocols. Additionally, you will be required to prepare regulatory responses and share process knowledge with cross-functional departments through presentations for smooth technology transfer. You will play a key role in reviewing and evaluating product history and process parameters for technical remediation and improvement of product robustness. Your duties will also include preparing and submitting investigation reports for OOS, OOT, and any failure during exhibit/validation/commercial batch manufacturing and stability testing. Furthermore, you will be responsible for tracking activities related to change control, CAPA, planned deviations, unplanned deviations, and more. Your role will involve preparing and reviewing product containment approaches, risk assessment reports for new products, elemental impurities, Nitrosamine impurities, and residual solvent. You will also be tasked with arranging placebos for quality control testing, change part development, and evaluating the feasibility of products. Statistical evaluation for process assessment, preparation and review of standard operating procedures, training schedules, conducting training sessions, and participating in regulatory audits to support the plant will also be part of your responsibilities. Overall, as a Manager-II in the MSTG department, you will be at the forefront of ensuring the quality and compliance of processes and procedures while contributing to the continuous improvement and development of new products within the organization.,

As a Supervisor at Sigachi located in Dahej, you will play a crucial role in ensuring the smooth production operations in line with GMP standards. Sigachi, a renowned manufacturer of Excipients for Pharma, Nutra, and food industries, has been a key player in the market since its inception in 1989. With multiple facilities in Telangana and Gujarat, Sigachi has solidified its position as a leading producer of Microcrystalline Cellulose globally. Operating under various certifications like EXCiPACT GMP, SGMP, HACCP, EDQM CEP, and ISO 9001:2015, Sigachi has built a reputation for delivering high-quality products across continents. Your primary responsibilities will include planning and organizing production schedules to meet targets for output, quality, and yield. You will oversee all production operations to ensure compliance with SOPs and GMP standards. Collaborating closely with the Quality Control department, you will focus on continuous improvement and effective resource utilization to maintain quality parameters. Additionally, you will coordinate with cross-functional teams, particularly the Engineering Department, to ensure the production of top-notch quality products. It will be your duty to provide on-the-job training for production staff and maintain updated training records. You will be responsible for reporting deviations, conducting investigations, and implementing corrective and preventive actions as necessary. Moreover, your role will involve coordinating with QA for batch release, investigating non-conforming batches, and ensuring batch identification and traceability. Maintaining equipment/instruments calibration, practicing good housekeeping, and adhering to gowning procedures are also part of your responsibilities. In terms of qualifications, we are looking for candidates preferably with a B.Sc, M.Sc, B.Pharm, M.Pharm, or B.Tech (Chemical) degree. An experience of 8 - 10 years in the Pharma Industry or Excipient Manufacturing sector will be highly advantageous for this role. If you are a self-driven professional with a keen eye for detail and a strong background in production operations, this position at Sigachi offers a challenging yet rewarding opportunity to showcase your expertise and contribute to the company's commitment to excellence.,

You will be responsible for line clearance activities before commencing operations, following the preventive maintenance schedule of machines, cleaning and sanitizing the visual inspection and packing area, operating the machines, and filling the log of the general area according to SOP and work execution. Additionally, you must adhere to cGMP, GDP, and maintain discipline in the department, ensuring all employees follow the same standards. Your duties will also include ensuring that all equipment and lines are in a validated and calibrated status, preparing daily production reports, and creating production planning on a monthly and daily basis based on requirements and material availability. You will handle tasks such as change control, deviations, CAPA, investigations, as well as document management including BMRs, BPRs, and master SOPs. Moreover, you will be responsible for preparing and reviewing protocols and reports as needed, overseeing the preparation, review, revision, control, and implementation of standard operating procedures in the sterile manufacturing department. Line clearance activities before commencing operations like manufacturing, sterilization, and filling are also part of your responsibilities, as well as checking records and logbooks related to various manufacturing processes. In addition to your defined job responsibilities, you may be required to perform other activities as instructed by the Head of Department (HOD) and provide training to subordinates, technicians, and operators. You must attend training sessions as per the schedule and ensure training aligns with the Training Needs Identification (TNI) process. Key Skills required for this role include adhering to Good Manufacturing Practices (GMP) and regulatory norms (USFDA, EU, WHO), accurately completing BMRs/BPRs, understanding deviations, change control, and CAPA, as well as the ability to inspire and guide others towards common goals while fostering a positive team environment. Qualifications: M.Sc. / B. Pharm / M.Pharm.,

As a Shift Operation Engineer, your responsibilities will include handling the shift operation and completing related documentation as required by SOP. You will be responsible for achieving targeted production, ensuring smooth, efficient, uninterrupted, and trouble-free operation and maintenance of the water plant, HVAC, and other utility equipment as per SOPs. Implementing best practices to comply with quality, safety, and regulatory requirements will be crucial in this role. Your tasks will also involve preparing, ensuring, and monitoring compliance of SOPs and related documentation of the engineering department. Initiating Change controls and Deviations, CAPA in the electronic system as per the need is essential. Monitoring operation, filter cleaning, filter replacement, and preventive maintenance activity of the HVAC system as per SOP, as well as checking and reviewing utility, water system, and HVAC Log books are part of your duties. It will be important to keep awareness of operational standards such as ISO 9001, ISO 14001, ISO 45001, and 13485, as well as following the regulations of various agencies like USFDA, EU, TGA, MHRA, ANVISA, WHO, Schedule M, etc. You will participate in qualification & requalification of machine/equipment and provide functional support for qualification, validation, and calibration activity. Active participation in DMS, OE, and EHS activities, as well as engagement in the process, will be required. Executing preventive maintenance plans of the respective area and ensuring good documentation and record-keeping are key tasks. Ensuring compliance of service floor activity and smooth operation and maintenance of utilities to provide uninterrupted services are also part of your responsibilities. Allocating jobs to workmen, supervising work for quality, and timely completion, as well as identifying repeated breakdowns and planning corrective actions to avoid recurrence with the engineering manager, will be important. Providing guidance and support to executives and workmen and imparting induction activity to all new joiners are also expected duties. Overall, your role will involve ensuring the proper working of HVAC systems & air conditioning units to maintain operational efficiency.,

You will be responsible for performing commissioning and qualification of Pharmaceutical equipment, specifically systems for Oral Solid Dosage, Injectables, and Fill/Finish. This includes a variety of equipments such as RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. Your responsibilities will include developing CQMP, VMP, FRA, cGMP review sheet, interdependencies, System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and cleaning validation protocol. You will execute Commissioning, qualification, and validation activities for Pharma Process Equipments for API, Fill/Finish, and OSD. Additionally, you will review, analyze, and interpret system performance data, handle deviations/discrepancies, conduct investigations, CAPA, and ensure promotion of cGMP and regulatory compliance in assigned projects. Furthermore, you will exercise good judgment in selecting methods and techniques for obtaining solutions, maintain GDP, ALCOA practices, and have hands-on experience with Pharma Process Equipments. Drafting equipment operation SOPs will also be a part of your role. Qualifications & Other Requirements: - BS/MS in Engineering (Chemical, Pharma). - 4-10 years of experience in validation, quality systems, operations, engineering, or a combination thereof. - Experience in multiple GMP validation disciplines with advanced technical knowledge. - Knowledge of Validation Lifecycle approach, international regulatory requirements, and standards. - Experience with Documentum or Maximo is a plus. - Strong verbal and written communication skills, excellent organizational and time utilization skills. - Ability to work independently and within project teams. - Industry experience related to cGMP drug manufacturing, validation, and chemical process design. - Strong computer knowledge including Microsoft Office products.,

The ideal candidate for this position should have a Diploma/BE/ME in Electrical with 6 to 10 years of relevant experience. The job is located near Vadodara and offers a salary of up to 9 LPA. As a Quality Lead, you will be responsible for implementing quality systems, conducting audits, and obtaining certifications such as ISO, UL, and VDE. You will also oversee internal, supplier, and customer audits, and work towards resolving quality issues using methodologies like 8D, RCA, and CAPA. Monitoring QA/QC operations including inspections, testing, and documentation will also be part of your responsibilities. In this role, you will define and track Quality KPIs, lead continuous improvement initiatives, and manage the quality team to ensure operational excellence. Collaboration with cross-functional teams such as Production, R&D, and Global Teams will be essential for the success of the quality function. To apply for this position, please reach out via mobile at 78628 40966 or visit www.crownhrservices.com/job-opening. This is a full-time position with benefits including Provident Fund. The work location is in person.,

Job Area: Finance & Accounting Group, Finance & Accounting Group > Internal Audit General Summary: Job Overview Qualcomm is a company of inventors that unlocked 5G - ushering in an age of rapid acceleration in connectivity and new possibilities that will transform industries, create jobs, and enrich lives. But this is just the beginning. It takes inventive minds with diverse skills, backgrounds, and cultures to transform 5Gs potential into world-changing technologies and products. This is the Invention Age - and this is where you come in. This is a unique opportunity to join Qualcomms finance and accounting organization based in Hyderabad in the Corporate Internal Audit & Advisory Services (IA & AS) team. The department focuses on assisting the Audit Committee and management teams in the improvement of processes that manage risks related to achieving Qualcomms business objectives. Using Qualcomms risk-based audit methodology, the senior auditor will assist in the execution of internal audits. Specifically, the responsibilities include: Providing U.S. based time zone coverage as needed (up to 50% of time) Supporting the creation of initial planning memos and process flowcharts Identifying and assessing initial risks and control activities Designing audit procedures to evaluate control effectiveness Performing audit testing, identifying deviations from expected control activities, and effectively communicating observations to the audit team Leveraging data analytics throughout the audit process where feasible Staying abreast of changes in business and industry to assess impacts on the companys risk profile Contributing to the development of new concepts, techniques, and making continuous process improvements for the overall IA team All Qualcomm employees are expected to actively support diversity in their teams, and in the Company. Minimum Qualifications Three to Five years of relevant experience in internal auditing, external auditing, or SOX compliance within a global public company (preferably in the high-tech industry), Big 4/mid-tier accounting firm or other fast-paced corporate setting Fluent English; multi-lingual capability is a plus Preferred Qualifications Successful candidate will possess the following characteristics: As feasible, ability to travel (infrequently) to Qualcomms domestic and international locations (e.g., U.S., Europe) Semiconductor business experience or familiarity Strong communication (oral and written) and presentation skills Fast learner with strong interpersonal, organization, analytical, critical thinking, and problem-solving skills Ability to work in a flexible and non-hierarchical team environment Willingness to get things done and take responsibility Ability to recognize and apply a sense of urgency, when necessary Comfortable with ambiguity Positive attitude, professional maturity, good work ethic Ability to work independently, handle multiple projects simultaneously and multi-task to meet deadlines with high-quality deliverables Keywords controls, risk assessment, risks, internal audit, SOX Educational Requirements Bachelors degree in accounting, Finance, Business Administration, or related field. CPA, CA, CIA, CFE, or other credentials, a plus. Minimum Qualifications: Bachelor's degree. 3+ years of Finance, Accounting, or related work experience. *Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience. Job Overview Qualcomm is a company of inventors that unlocked 5G - ushering in an age of rapid acceleration in connectivity and new possibilities that will transform industries, create jobs, and enrich lives. But this is just the beginning. It takes inventive minds with diverse skills, backgrounds, and cultures to transform 5Gs potential into world-changing technologies and products. This is the Invention Age - and this is where you come in. This is a unique opportunity to join Qualcomms finance and accounting organization based in Hyderabad in the Corporate Internal Audit & Advisory Services (IA & AS) team. The department focuses on assisting the Audit Committee and management teams in the improvement of processes that manage risks related to achieving Qualcomms business objectives. Using Qualcomms risk-based audit methodology, the senior auditor will assist in the execution of internal audits. Specifically, the responsibilities include: Providing U.S. based time zone coverage as needed (up to 50% of time) Supporting the creation of initial planning memos and process flowcharts Identifying and assessing initial risks and control activities Designing audit procedures to evaluate control effectiveness Performing audit testing, identifying deviations from expected control activities, and effectively communicating observations to the audit team Leveraging data analytics throughout the audit process where feasible Staying abreast of changes in business and industry to assess impacts on the companys risk profile Contributing to the development of new concepts, techniques, and making continuous process improvements for the overall IA team All Qualcomm employees are expected to actively support diversity in their teams, and in the Company. Minimum Qualifications Three to Five years of relevant experience in internal auditing, external auditing, or SOX compliance within a global public company (preferably in the high-tech industry), Big 4/mid-tier accounting firm or other fast-paced corporate setting Fluent English; multi-lingual capability is a plus Preferred Qualifications Successful candidate will possess the following characteristics: As feasible, ability to travel (infrequently) to Qualcomms domestic and international locations (e.g., U.S., Europe) Semiconductor business experience or familiarity Strong communication (oral and written) and presentation skills Fast learner with strong interpersonal, organization, analytical, critical thinking, and problem-solving skills Ability to work in a flexible and non-hierarchical team environment Willingness to get things done and take responsibility Ability to recognize and apply a sense of urgency, when necessary Comfortable with ambiguity Positive attitude, professional maturity, good work ethic Ability to work independently, handle multiple projects simultaneously and multi-task to meet deadlines with high-quality deliverables Keywords controls, risk assessment, risks, internal audit, SOX Educational Requirements Bachelors degree in accounting, Finance, Business Administration, or related field. CPA, CA, CIA, CFE, or other credentials, a plus. Applicants Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail disability-accomodations@qualcomm.com or call Qualcomm's toll-free number found here. Upon request, Qualcomm will provide reasonable accommodations to support individuals with disabilities to be able participate in the hiring process. Qualcomm is also committed to making our workplace accessible for individuals with disabilities. (Keep in mind that this email address is used to provide reasonable accommodations for individuals with disabilities. We will not respond here to requests for updates on applications or resume inquiries). Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. To all Staffing and Recruiting Agencies Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. If you would like more information about this role, please contact Qualcomm Careers.