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
Skills & Competencies
Strong knowledge of cGMP, GDP, and Quality Systems
Hands-on experience with batch documentation and document control systems
Good understanding of APQR preparation and regulatory expectations
Strong analytical, organizational, and coordination skills
Effective communication and cross-functional collaboration abilities
Attention to detail and commitment to data integrity
Key Responsibilities
Review of Master Documents
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.
cGMP Training Coordination
Coordinate and monitor cGMP and quality-related training programs for site personnel.
Maintain trainingschedules, records, and effectiveness assessments.
Archival & Records Retention
Manage the archival room and document storage systems for controlled and historical GMP documents.
Ensure secure storage, easy retrieval, retention compliance, and protection against unauthorized access or damage.
Support audits and inspections by ensuring availability of archived records.
