Quality Assurance Lead - Drug Substance

Experience: 18 -22 Years

Department: Quality Assurance

Job Summary

We are looking for an experienced Quality Assurance professional with extensive expertise in biologics and biopharmaceutical manufacturing. The ideal candidate should have strong knowledge of GMP compliance, IPQA operations, validation activities, quality systems, regulatory documentation and manufacturing processes.

Key Responsibilities

1. Handle all IPQA-related activities and ensure facility GMP compliance.
2. Review executed batch manufacturing records and associated checklists.
3. Review study protocols, process validation and cleaning validation protocols and reports.
4. Review technology transfer documents related to cell banks, inoculum and downstream processing.
5. Review change control activities related to cell banks, inoculum and downstream operations.
6. Review investigation reports pertaining to downstream deviations.
7. Ensure effective CAPA implementation and verification of CAPA effectiveness.
8. Support regulatory activities by reviewing and preparing required documentation for regulatory filings.
9. Review and prepare site-specific Quality Assurance SOPs.
10. Review production SOPs and ensure compliance with quality standards.
11. Ensure audit readiness, shop-floor oversight and GMP compliance.
12. Support audit preparation, audit handling and closure of audit observations.
13. Review Continued Process Verification (CPV) parameters from Production, QC and control systems, including data trends.
14. Coordinate QA activities for new product initiation in Drug Substance (DS) manufacturing facilities and manage cross-functional requirements.

Educational Qualification

• B.Sc. / M.Sc. in Biotechnology, Microbiology, Biochemistry or Life Sciences.
• B.Pharm / M.Pharm.
• B.Tech / M.Tech in Biotechnology or Chemical Engineering.
• Relevant postgraduate qualifications will be preferred.