- 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 ofexisting 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

📌 Engineering & Manufacturing Specialist (Pune)
🏢 LUPIN
📍 Pune