Role & responsibilities
- Supervise and manage all production activities during the assigned shift to ensure adherence to production schedules.
- Ensure compliance with cGMP, GDP, EHS, SOPs, and company quality standards.
- Monitor and control API manufacturing processes including reaction, distillation, filtration, centrifugation, drying, milling, and blending operations.
- Ensure timely availability of raw materials, solvents, utilities, and manpower for smooth production operations.
- Verify line clearance, equipment readiness, and production documentation before batch initiation.
- Review and maintain Batch Manufacturing Records (BMR), logbooks, equipment usage records, and shift reports.
- Monitor critical process parameters and ensure operations are performed within validated process limits.
- Coordinate with QA, QC, Warehouse, Engineering, Utility, and EHS teams for uninterrupted production activities.
- Investigate process deviations, equipment breakdowns, and production issues,
and participate in Root Cause Analysis (RCA) and CAPA implementation.
- Ensure proper cleaning, changeover, and sanitization of equipment as per SOPs.
- Supervise and guide production operators and technicians to achieve shift production targets.
- Optimize manpower utilization, equipment efficiency, and production productivity.
- Participate in process validation, cleaning validation, media fills (if applicable), and technology transfer activities.
- Ensure compliance with safety practices, Permit to Work (PTW), Lockout/Tagout (LOTO), and hazardous chemical handling procedures.
- Support regulatory inspections and customer audits by ensuring documentation and production readiness.
- Drive continuous improvement initiatives to enhance productivity, reduce cycle time, improve yield, and minimize batch failures.
Regards, Dhivakar D
[email protected]
📌 Shift Incharge - API Production (Chennai)
🏢 BVR People Consulting
📍 Chennai