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

Work arrangement
No