Senior Manager

✔EnablingthesuccessfultransferandscaleupofthetechnologiesfromR&Dto Manufacturing Site and conductingProcess and Cleaning Validations and related Investigation.✔ExecutingtheTeamBuildingActivitiesandWorkshopattheSitetopromote Employee Engagement.✔EnsuringtheValidations and Qualification atSite.✔Execution of Management Quality Review at Site.✔Ensuringthe Manufacturing and/or Control of Drug Substance and Drug Products in cGMPCompliance.✔RiskAssessmentandControlbydesigningofCAPAplantomitigatetheassociated Risk.✔ Strong leadership/managementskills, including team management, supervision,and coaching.✔Ensure compliance to regulatory requirements like cGMP, USFDA & WHOetc.✔ Management of Incidents,Deviation and Implementation of Change ControlSystem to eliminate any discrepancies and non-compliance for ContinualSystem Improvement.✔ Investigation of Root Causeof Audit findings, Product Complaints, Incidents, Deviations, OOS/OOT/Atypicaletc.✔ Compilation of ManagementQuality Review Report with Quality Indicating Parameters. Management ofRegulatory Audits andconductingInternalAuditsina roleof Lead /Co-auditor, Compilation of Audit Report, Risk Ranking and Review ofAudit Response.✔Handlingof Product Complaints and Regulatory Queries and preparation of response.✔ Management ofcontrol sample.✔ Release/Reject of Finish Product.✔ Handling of product Recall.✔ Preparation of RollingProduct Quality Review & CPV.✔ Preparation and review ofGap Assessment for introduction of new system, facility, new product withrespect to existing system, facility.✔ Write & review policydocuments like VMP, SMF.✔ Development/Review of all protocol/Master document jointly with userdepartment.