12/11 Vito India
HR at Native

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AGM/ DGM - Quality Assurance (10-25 yrs)

Goa/MP Job Code: 19890

- 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.

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

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