Dsp Supervisor

Execute and supervise batch activities in accordance with BMRs and established protocols Prepare revise execute and review Batch Manufacturing Records BMRs PDR SOPs Protocols Having strong knowledge of Chromatography techniques UFDF Column packing-unpacking Should be well versed with continuous centrifugation Homogenizer and single-use technology Collaborate with Process Development MSAT and Operational Excellence teams for process scale-up and technology transfer activities Prepare and review qualification documents as per SOPs ensuring timely review and approval with cross-functional teams Execution of Installation Operational and Performance Qualification IQ OQ PQ for downstream equipment Coordinate Commissioning Qualification activities through collaboration with internal and external cross-functional teams and subject matter experts SMEs Coordinate with the maintenance department for the upkeep of operational equipment Ensure all operational documents batch records and checklists are compliant with cGMP Should have good knowledge about process mapping and equipment mapping as per project requirements Coordination with the client for finalization of process requirements and address client quarries related to project Manage the stock of required consumables for batch activities and ensure timely procurement Prepare and review quality protocols and investigate any batch failures in operations Support the facility s readiness for regulatory inspections Having strong knowledge of QMS activities Change Control Deviation CAPA Investigation etc Report deviations and manage change controls collaborating with QA to implement corrective actions Carry out additional tasks as assigned by the HOD