GMP Coordinator – Quality Assurance

About the role

The GMP Coordinator will ensure that all manufacturing processes and the plant environment comply with Good Manufacturing Practice (GMP) standards and approved SOPs. Reporting to the Quality Assurance Manager, the role supports product quality, documentation control, and regulatory compliance within the pharmaceutical manufacturing site.

Key responsibilities

• Monitor manufacturing processes and plant environment to ensure GMP compliance and adherence to SOPs.
• Coordinate calibration of balances and measuring devices across the plant.
• Verify manufacturing orders and manage sampling of intermediates for quality evaluation.
• Oversee product stability studies, temperature mapping, and the issuance, retrieval, control, and archiving of GMP‑related documents.
• Prepare and coordinate Product Quality Reviews (PQRs) and other quality reports.
• Participate in internal quality, housekeeping, and regulatory audits, and conduct GMP, GLP, and laboratory safety training for relevant staff.
• Assist in assessment of returned goods, product recalls, and imported product evaluations.
• Support broader Quality Assurance activities and deputize for the Quality Assurance Manager when required.

Required profile

• Minimum 3 years of experience in a pharmaceutical manufacturing environment, preferably within Quality or Quality Assurance.
• Bachelor’s degree in Pharmacy, Biochemistry, Microbiology, or a related science discipline.
• Certification in a quality‑related discipline is an advantage.
• Training or knowledge in Statistics and Pharmaceutical Quality Management is desirable.
• Strong documentation, report‑writing, supervisory and people‑management skills.
• Excellent organisational abilities with high attention to detail.

Required skills

• Good knowledge of GMP and pharmaceutical manufacturing operations.
• Experience with calibration coordination and equipment validation.
• Document control and archiving of GMP‑related records.
• Preparation of Product Quality Reviews and other quality documentation.
• Conducting internal audits, GMP/GLP training, and safety training.
• Assessment of product recalls, returned goods, and imported product compliance.
• Statistical analysis and pharmaceutical quality management concepts.