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AGM/DGM - Quality Assurance - Pharma

10.00 to 14.00 Years   Indore   19 Jan, 2023
Vito India
Job LocationIndore
EducationNot Mentioned
SalaryNot Disclosed
IndustryManagement Consulting / Strategy
Functional AreaGeneral / Operations Management
EmploymentTypeFull-time

Job Description

    AGm/ DGM - Quality Assurance- 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.,

Keyskills :
continuous improvement facilitationtime studyshop floorbatch releasequality assurancechange managementmarket complaintsquality management

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