Role & responsibilities: -

- Production Supervision: Supervise daily operations across sterile compounding, aseptic filtration, filling, sealing, and lyophilization (freeze-drying) lines for ampoules and vials.
- Equipment Troubleshooting: Operate, calibrate, and troubleshoot critical machinery including vial washing systems, depyrogenation tunnels, autoclaves, and high-speed filling lines.
- cGMP & Audit Compliance: Ensure strict adherence to current Valuable Manufacturing Practices (cGMP) and actively participate in regulatory audits like USFDA, EMA, and MHRA.
- Validation & Media Fills: Lead and document line validation activities, equipment qualifications, and routine media fill trials to ensure cleanroom sterility.
- Documentation Review: Author and review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and line logs in real-time, enforcing strict data integrity.
- Deviation & CAPA Management: Investigate shop-floor deviations, conduct root-cause analysis (RCA),



and implement effective Corrective and Preventive Actions (CAPA).
- Environmental Monitoring: Oversee Grade A/B/C/D cleanroom parameters, including differential pressure, viable/non-viable particle counts, temperature, and humidity.
- Material Reconciliation: Manage the dispensing of raw materials and execute precise product reconciliation at every stage of the manufacturing cycle.
- Team Leadership: Lead and train a shift team of junior officers, technicians, and operators to maintain optimum line efficiency and safety.
- Cross-Functional Coordination: Collaborate daily with Quality Assurance (QA), Quality Control (QC), Engineering, and Warehouse teams to ensure smooth batch releases.

Preferred candidate profile: -

- Required Experience: - 3 to 10 Years
- Required Educational Qualification: - M.Pharm. / B. Pharm.

Regards, Human Resources Department,

Intas Pharmaceuticals SEZ Plant

📌 Walk-in Drive For Officer / Executive - Injectable Manufacturing (Ahmedabad)
🏢 Intas
📍 Ahmedabad