AGM/ DGM - Quality Assurance (10-25 yrs)
- Monitor quality indicators for operations and ensure controls are in place & maintained for cGMP activities.
- Monitor Manufacturing and Packing activities to ensure compliance to the systems and procedures as per cGMP. Responsible for trending of quality indicators in manufacturing operations.
- Provides technical, quality oversight and in making quality decisions on hold, High Risk Deviations from the manufacturing/packaging areas quality driven metrics.
- Approval of documents associated with key quality compliance indicators- Deviations, OOS/OOT, market complaints, product recalls, CAPAs, change controls, process validation protocols, and reports.
- Perform periodic reviews of Quality performance parameters and recommend appropriate remedial actions as applicable.
- Handling of Deviation Management, Market Complaints, OOS/OOT, Failure Investigation and CAPA and Change Management
- Vigilance of all manufacturing and packaging operations to ensure shop floor compliance & All-Time Readiness (ATR)
- Continuous Improvement on Shop floor by implementing various practices such as AQL qualification, sampling qualification, Line Clearance Qualification, Use of Vertical Samplers.
- Well versed with MES, QAMS, SAP, LIMS, eBMR (Syncade), UL Compliance Wire applications.
- Participate in designing Quality Management Systems and updating GMP documents as per regulatory amendments and process requirements.
- To report and investigate Deviations, Incidences and Non-conformance observations.
- Line clearance prior to dispensing, manufacturing, filling, and packaging activity, Verification of challenge tests for all equipment whenever applicable.
- Conduct in-process tests as per the requirements of the process and batch record.
- Verify the calibration of all instruments on various equipment and balances. Preventive maintenance status of equipment.
- Review of Batch Production Records and batch release and related log books.
- Inventory management of QA department.
- To conduct and monitoring of Process validation, Process verification, cleaning validation and Hold time study of various products.
- To review Master documents like Batch manufacturing records and Batch Packing records.
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