Production Operations
- Plan, execute, and monitor day-to-day injectable manufacturing operations (Liquid / Lyophilized / SVP / LVP).
- Ensure adherence to batch manufacturing records (BMR) and standard operating procedures (SOPs).
- Coordinate with Planning, QA, QC, Engineering, and Stores for smooth production activities.
- Monitor in-process checks and ensure timely completion of batches.
- Ensure line clearance before starting operations.
Compliance & Documentation
Ensure compliance with cGMP, WHO, USFDA, EU, MHRA, and other regulatory standards.Review and approve BMR, BPR, and related production documentation.Participate in internal and external audits (regulatory and customer).Initiate and handle deviations, CAPA, and change controls effectively.Manpower & Training
Supervise and train production executives, officers, and operators.Plan manpower deployment and shift scheduling.Conduct on-the-job and periodic GMP training programs for team members.Equipment & Process Management
Ensure proper operation, cleaning, and maintenance of manufacturing and sterilization equipment (Autoclaves, Filling Machines, LAFs, Compounding vessels, etc.).Coordinate with the Engineering department for preventive and breakdown maintenance.Participate in equipment qualification and process validation activities.Process Improvement & Efficiency
Identify areas for productivity improvement and cost reduction.Support technology transfer, scale-up, and new product introduction.Drive continuous improvement initiatives like 5S, Kaizen, and Lean Manufacturing.Skills Required
Usfda, Sterile, Filling, lyophilization, Kaizen Facilitation