Job Description
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- GMP Compliance – Drug Product Facilityn
- 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.n
- Coordinate with Drug Product (DP) teams for smooth batch execution from dispensing to dispatch.n
- Review technical documents related to drug product manufacturing.n
- Media Fill, Validation, and Qualificationn
- Review media fill protocols and reports in compliance with current regulatory guidelines. Ensure equipment and area qualifications, including periodic requalification for drug product facilities.n
- Review process validation and cleaning validation protocols and reports.n
- Ensure availability of visual inspection qualification kits.n
- Contract Manufacturing Organizations (CMOs) Activitiesn




- Ensure manufacturing and analytical activities at CMOs are conducted in compliance with Quality Technical Agreements and cGMP requirements.n
- Coordinate and communicate with CMO manufacturing and analytical teams for timely execution and tracking of activities.n
- Identify the need for current procedures and ensure their implementation; perform gap analysis of existing procedures.n
- Review executed Batch Processing Records (BPR) and Analytical Records (AR) for batch release, and coordinate with CMOs to ensure compliance.n
- Review and approve Annual Product Quality Review (APQR) reports for products manufactured at CMOs.n
- Market Complaint and Recall Activitiesn
- Manage market complaints including registration, communication with complainants and DSRM, investigation, and implementation of corrective and preventive actions (CAPA).n
- Notify stakeholders regarding product or batch recalls/market withdrawalsn

📌 Quality Assurance Manager (Pune)
🏢 LUPIN
📍 Pune