Production
● Supervise and coordinate all manufacturing operations from start to finish: dispensing, mixing, wet granulation, fluid bed drying, milling, blending, compression, coating, encapsulation, oral liquid preparation and filling, and primary and secondary packaging (blistering, Alu-Alu, bottling, cartoning).
● Plan and manage daily production schedules in line with orders and inventory targets.
● Oversee equipment qualification (IQ, OQ, PQ) for all production and packaging machinery.
● Review and approve Batch Manufacturing Records (BMRs) and ensure all production steps follow approved SOPs.
● Ensure correct weighing, dispensing and in-process controls for all raw materials, granules and intermediates.
● Monitor critical process parameters (granule moisture, hardness, friability, disintegration, dissolution, weight variation, fill volume) and take corrective action as needed.
● Manage changeover, line clearance and cleaning validation for all production equipment.
Formulation
● Develop and optimise formulations from reference products and pharmacopoeia monographs; manage scale-up to commercial batches.
● Prepare product dossiers; review supplier CoAs, specifications and technical data.
Quality Assurance
● Set up and maintain the Quality Management System to WHO-GMP and PIC/S PE 009-17.
● Write and approve SOPs; manage deviations, CAPA, change control and OOS investigations.
● Run self-inspections, qualify suppliers, and prepare the plant for AFDA and other GMP inspections.
● Oversee process, cleaning and analytical method validation.