Job Purpose
To plan, organize, supervise and control pharmaceutical production activities to ensure that products are manufactured safely, efficiently, on schedule and in accordance with approved procedures, batch documentation, GMP requirements and the company quality system.
Key Responsibilities
· Prepare and implement daily, weekly and monthly production plans in coordination with QA, QC, Warehouse, Engineering/Technical and other relevant departments.
· Ensure manufacturing operations are performed according to approved Master Formula, Batch Manufacturing Record (BMR), Batch Packaging Record (BPR), SOPs and approved process parameters.
· Supervise production personnel, allocate duties and ensure adequate manpower for each production activity and shift.
· Ensure proper line clearance, equipment status identification, material verification and prevention of mix-ups and cross-contamination.
· Monitor production yield, material consumption, rejects, waste, downtime, productivity and process performance.
· Coordinate equipment maintenance, calibration, qualification and validation activities with the Technical/Engineering and Quality departments.
· Ensure proper cleaning, sanitation and housekeeping of production areas and equipment.
· Review completed production records for completeness and accuracy before submission to QA.
· Report deviations, equipment failures, abnormal process conditions and other production incidents and participate in investigations and CAPA.
· Support change control, risk assessment, process improvement and continuous improvement activities.
· Ensure personnel follow gowning, hygiene, safety and GMP requirements.
· Identify training needs and provide or coordinate training for production personnel.
· Coordinate production priorities with Warehouse and QC to ensure timely availability and release of materials and products.
· Prepare production performance reports and communicate major operational risks to management.