Design, implement, and maintain the facility's Quality Management System, ensuring all operational processes align with national regulatory standards (such as NAFDAC, SON).
Review and approve Standard Operating Procedures (SOPs), batch manufacturing records, specifications, and validation protocols to uphold data integrity and ensure that it is duly followed by staff.
Lead investigations into manufacturing or laboratory deviations, out-of-specification (OOS) results, and customer complaints using root cause analysis, followed by implementing Corrective and Preventive Actions (CAPAs).
Plan and execute internal self-inspections, qualify external raw material suppliers and contractors, and lead the facility during official regulatory agency inspections.
Oversee quality approval for the qualification and validation of manufacturing equipment, computer systems, and critical plant processes (IQ, OQ, PQ).
Conduct final reviews of production data and authorize the disposition or market release of pharmaceutical batches.
Manage the Quality department staff and ensure that they work effectively and efficiently.
Manage comprehensive GMP training matrices for personnel across departments to maintain a high standard of regulatory awareness and competency.
Professional requirements (minimum): BSc, B.Pharm, or HND