Quality Assurance Officer

• Ensure compliance with GMP, GLP, GDP, and company SOPs.
• Prepare, review, issue, and control SOPs, BMRs, BPRs, specifications, and other quality documents.
• Review batch manufacturing records (BMR) and batch packing records (BPR) before batch release.
• Conduct line clearance before the start of manufacturing and packaging activities.
• Perform in-process quality checks during production and packing.
• Handle deviations, change controls, CAPA, OOS, OOT, and customer complaints.
• Review and approve analytical reports, certificates, and quality documentation.
• Conduct internal audits and support external regulatory audits.
• Monitor environmental conditions, housekeeping, and GMP compliance across production areas.
• Ensure calibration and validation activities are completed as per schedule.
• Coordinate with Production, QC, Warehouse, and Regulatory Affairs departments.
• Maintain document control and ensure proper record retention.
• Conduct GMP training for employees and maintain training records.
• Support product release activities and ensure compliance with regulatory requirements.

Required Skills

• Good knowledge of GMP, GLP, GDP, WHO-GMP, and regulatory guidelines.
• Understanding of pharmaceutical quality systems and documentation.
• Knowledge of CAPA, Change Control, Deviations, OOS, and OOT investigations.
• Strong documentation and analytical skills.
• Good communication and problem-solving abilities.
• Proficiency in MS Office and ERP systems is an added advantage.