About this role
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