Manager – Quality Assurance GMP Compliance – Drug Product Facility • Monitor day-to-day activities and plan allocation of IPQA personnel as per batch schedule. Oversee critical manufacturing activities including dispensing, in-process checks, sampling, filling, sealing, visual inspection, and AQL.

- Coordinate with Drug Product (DP) teams for smooth batch execution from dispensing to dispatch. Review technical documents related to drug product manufacturing.

Media

Fill, Validation, and Qualification • Review media fill protocols and reports in compliance with current regulatory guidelines. Ensure equipment and area qualifications, including periodic requalification for drug product facilities.

- Review process validation and cleaning validation protocols and reports. Ensure availability of visual inspection qualification kits.

Contract Manufacturing

Organizations (CMOs) Activities • Ensure manufacturing and analytical activities at CMOs are conducted in compliance with Quality Technical Agreements and cGMP requirements.





- Coordinate and communicate with CMO manufacturing and analytical teams for timely execution and tracking of activities.
- Identify the need for current procedures and ensure their implementation; perform gap analysis of existing procedures.
- Review executed Batch Processing Records (BPR) and Analytical Records (AR) for batch release, and coordinate with CMOs to ensure compliance.
- Review and approve Annual Product Quality Review (APQR) reports for products manufactured at CMOs.

Market

Complaint and Recall Activities • Manage market complaints including registration, communication with complainants and DSRM, investigation, and implementation of corrective and preventive actions (CAPA).

- Notify stakeholders regarding product or batch recalls/market withdrawals. Work Experience 10-15 Years of relevant work experience in Biopharma Education Masters in Biotechnology or Biopharmaceutics Post Graduation in Pharmacy Competencies Experience Level Mid Level

📌 Quality Assurance Manager (Pune)
🏢 Lupin
📍 Pune