Quality Assurance Specialist

6 hours ago


Bengaluru, India Syngene International Limited Full time

Core Purpose of the Role:Experience - 8 to 10 yearsLine Clearance process overview, Product change over.Timely area readiness (Cleaning, EMS, OOS status) and ensures availability of documents and material status.Monitoring of process through process step verification.Reviewal of Batch Manufacturing Record to check compliance from stepwise process execution till written instructions.Equipment / utility Qualifications, Calibrations, PM verification.Utility / Computer system validationProcess validation and cleaning validation.Target Monitoring for batch related process activities.cGMP compliance and verification overview of BMP facility & Utilities.SOP preparation and review.TrainingGEMBA principlesQuality management system, investigatio



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