- To prepare & review the quality assurance SOPs, and to verify effectiveness of SOP management system.
- To review the Batch Manufacturing Record (BMR), Batch Packing Record (BPR).
- To participate, coordinate & verify the effectiveness of Quality Risk Management study.
- To participate in investigation of Complaint, Deviation & Batch Failure.
- To conduct & Coordinate self-inspection of various department as per approved schedule / Planner.
- To ensure effective implementation of corrective and preventive actions.
- To perform site audit of vendors, external Laboratories & Service providers.
- To monitor Quality Management Systems w.r.t. approved action plan / schedule / planner.
- To monitor & coordinate the QMS & Documentation team includes following:
- Preparation & review of Batch Manufacturing Record & Batch Packing Record.
- Issuance of Batch Manufacturing Record and Analytical work protocols as per daily production planning.
- Issuance of Batch Packaging Record as per daily packaging plan.
- Issuance of Format, Registers & Booklets as per requirements.
- Preparation, issuance & control of Standard Operation Procedures.
- Coordination & Execution of Training & Self-inspection programmes
Experience : 6 - 7 Years
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Production, Manufacturing, Maintenance
End Date : 15th September, 2018
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