- Supervise aseptic processing: Monitor formulation, sterile filtration, filling, sealing, and lyophilization (freeze-drying) operations.
- Manage cleanrooms: Ensure strict environmental monitoring, proper pressure differentials, and air velocity in Grade A to D cleanrooms.
- Oversee lines: Control high-speed lines for vials, ampoules, Prefilled Syringes (PFS), and Large Volume Parenterals (LVP).
- Maximize resource use: Allocate manpower and manage shift schedules to achieve daily production targets efficiently
- Maintain batch records: Complete and review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) online during operations.
- Handle deviations: Initiate and document QMS elements like deviations, change controls, and Corrective and Preventive Actions (CAPA).
- Write SOPs: Draft, review, and update Standard Operating Procedures (SOPs) for machinery and processes.
- Support audits: Cooperate with Quality Assurance (QA) to face internal and regulatory audits (e.g., USFDA, MHRA, WHO-GMP)
- Validate processes: Coordinate and participate in media fills, equipment qualifications (IQ/OQ/PQ), and process validations.
- Monitor calibrations: Check that all measuring instruments, autoclaves, and tunnels are calibrated according to schedule.
- Fix breakdowns: Coordinate with the engineering team to resolve shift equipment issues quickly and minimize downtime
Pay: ₹30,000.00 - ₹40,000.00 per month
Benefits:
- Food provided
- Provident Fund
Work Location: In person
