- 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
- Positive 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.