"Overseeing site activities including project planning, system validation, production and dispatch planning, PO review, troubleshooting, cost reduction, QMS final approval, and ensuring market compliance."

I have successfully completed the project like facility qualification and equipment qualification as per given time line Rubella viruses,Measles viruses and Cell culture also, additionally I am leading QMS and SAP PM activity

I have worked in the COVID-19 vaccine project from Dec 2021 to Nov 2022 and I managed Process Management, SAP PM, QMS leading and requalifications of area and equipment in both DS and DP.

I am working as a part of SMT member (Self Managed Team)Subject Matter Expert (SME) in my teamBioprocess managementUpstream ProcessDSP ProcessPacking relatedTroubleshooting SAP PMPlanning and Management Helping to the team for perform well

Laying down cell bank for commercial process ensuring compliance to statutes.-Managing inoculum development activities for production batches as per schedule minimizing process delays.-Scale down studies for process improvement and optimization.-Addressing and investigation of process descrepencies, initiation of change controls, revision and reviewing of batch production records and SOPs.- Commissoning and qualification of production systems and equipments, ensuring facility readiness for daily activities.

Working in Small Scale Cell Culture. Dealing with seed development and scale up from WCB to Production fermenter through spinners and seed fermenter stages. Involved in qualification of new as well as existing equipments and validaiton activities.Trainee Officer ProductionWorked with completely automated (SCADA linked) 40L and 125L dual bioreactors and carried out all assesory operations like ESIP, FSIP, CIP etc.-Trained in integrity testing of hydrophobic/hydrophilic filters using Sartocheck 3.- Trained in down stream processing techniques viz continous centrifugation, TFF systems, chromatografic techniques.- Worked with AKTA pilot with BPG 200/500 column.-Trained in working asceptically in clean room environments.- Engaged in preparation of P&IDs and validation master plans.