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.
