Manager – Quality Assurance

Job Description 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 new 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