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A leading biopharmaceutical company (ENZBIO) is hiring an Executive – Quality Assurance (IPQA) for its Pune, Maharashtra facility. This permanent role is ideal for professionals with strong experience in In-Process Quality Assurance (IPQA), GMP compliance, analytical QA review, and validation activities within a regulated biologics or pharmaceutical manufacturing environment.
If you are looking to advance your career in biopharma QA, with hands-on exposure to manufacturing oversight, data integrity (ALCOA+), CPV, and QMS, this opportunity offers excellent professional growth.
Key Responsibilities – Executive QA IPQA
IPQA & Manufacturing Oversight
- Perform line clearance for new batches, raw material dispensing, cell bank issuance, and Drug Substance (DS) handling.
- Provide in-process QA oversight during manufacturing to ensure adherence to approved procedures and cGMP requirements.
- Review and approve Batch Manufacturing Records (BMRs) and batch documentation for accuracy, completeness, and compliance.
Analytical QA & Data Integrity
- Review analytical QC documents, specifications, and test procedures.
- Conduct audit trail reviews for critical QC instruments and process equipment to ensure data integrity and ALCOA+ compliance.
- Support QA operations using eDMS and electronic quality management systems.
Validation & CPV
- Review Continued Process Verification (CPV) data, trend analysis, and compliance status.
- Review Process Validation and Cleaning Validation protocols and reports to ensure regulatory adherence.
Deviations, Breakdowns & Complaints
- Manage breakdown-related QA activities and acknowledge quality events from user departments.
- Support investigations, documentation, and closure of deviations and complaints related to manufacturing and QC operations.
Documentation & QMS Support
- Prepare, review, approve, and control SOPs and quality documents in line with QMS requirements.
- Ensure timely documentation, effective version control, and regulatory compliance.
Qualifications Required
- M.Pharm or M.Sc (Chemistry / Biotechnology / Microbiology or related discipline)
Experience Required
- 3 to 6 years of relevant experience in the biopharmaceutical or pharmaceutical industry
Skills & Competencies
- Strong hands-on experience in IPQA activities and analytical document review
- In-depth knowledge of cGMP guidelines and data integrity principles
- Experience with eDMS / electronic quality systems
- Good understanding of validation, CPV, and batch documentation
Salary & Benefits
- Estimated Salary: ₹6,00,000 – ₹10,00,000 per annum (CTC), depending on experience and skill set
- Permanent employment with structured QA processes
- Exposure to regulated biopharmaceutical manufacturing
- Career growth in Quality Assurance and Compliance
Job Location
📍 Pune, Maharashtra, India