Executive - Quality Assurance (Pharmaceuticals)
External
Zentiva · IndiaPrepare for this interview
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About the role
Job Title- Executive Quality Assurance (Pharmaceuticals) Educational requirement B.Pharm or M.Pharm with 1-5 years of experience. Quality Management/Continuous Improvement Line Clearance and shop floor compliance Carry out in-process checks and calibration of IPQC instruments. Handle e tools i.e. SAP Hana, LIMS, eDMS, Track Wise system. Assisting in Complaint Investigation system at site Assisting in Q ualification and validation system, change control system, deviations Preparing & review the Annual Product Quality Review Review of Batch Manufacturing & Packing Records Coordination of cGMP Training activity . Compliance Ensure adherence to company Quality Standards, Local EU, FDA , MHRA regulations, by Understanding the requirements Performing the Gap analysis to find out the gaps in existing system Preparing a compliance plan for closure of gaps Execution of compliance plans Review of completion for compliance activity Validation s & Qualifications : Ensure validated status of all equipment 's , manufacturing processes, and cleaning processes Review of protocols for qualification and validation of facility/ equipment / product / process Review of validation reports after execution of validation of facility /equipment / product / process Documentation Control: Preparation and Review of SOPs Controlled distributi on and archival of documents & record Control of master documents Assuring quality of products by : Ensuring SOP compliance Review of Batch Manufacturing & Packing Records Ensuring implementation of Corrective actions/Preventiv e actions proposed in Deviations and Customer complaints Ensuring the effectiveness review of the implemented CAPA cGMP Training : To prepare training modules and organize training in GMP E xecute the training program in coordination with all concerned departments Other: Review of maintenance and calibration program .
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