- 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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