Walk-in Drive For Officer / Executive - Injectable Manufacturing

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 Good 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