Review and maintain Master Batch Manufacturing Records and Master Batch Packing Records to ensure accuracy, regulatory compliance, and alignment with approved specifications and process related changes.
Coordinate with Production, QC, and Regulatory Affairs for timely updates and approvals.
Annual Product Quality Review (APQR)
Prepare, compile, and review Annual Product Quality Reviews (APQRs) in line with regulatory expectations.
Support identification of improvement opportunities and follow-up of CAPAs arising from APQR findings.
Qualification & Experience
Qualification
Bachelor’s or master’s degree in pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline.
Experience
1–5 years of relevant experience in Pharma Quality Assurance / Documentation