Sumit Sahay

Background

About Sumit Sahay

Working in Zydus Lifesciences as Assistant Manager with 13 years of experience in Quality Management System, Analysis & Testing, Validation, Review and Method updationHandling team of 19 Employees, work allocation.Handling CAPA, Deviations, Method Validation such as MLT VALIDATION,BET VALIDATION.Disinfectant Efficacy Test, Growth Promotion Test,Media preparation and Sterilisation and destruction.Qualification/Requalification such as DQ,IQ,OQ, PQ of Equipment/ Instruments of Microbiology Dept and HVAC validation.Proficient at Reviewing Water Analysis, BET, Microbial Limit Test, Growth Promotion Test.Handling deviations and change controls, out of Specification and out of Trends etc. Heading & Leading activities performed in the microbiology laboratory. plan, monitor and organize testing activities. To ensure the testing and releasing of raw material, packing material and finished product from microbiology laboratory and reviewing the results.To verify all the test reports and related documents and monitoring of cGLP norms in the microbiology laboratory.Internal and external audit compliance such as Glennmark audit,Aspiro audit,TGA audit, USFDA audit.Internal audits compliance.Responsible for internal / Customer / Regulatory audits and preparation of reports.To review the validation / qualification protocol and report of the equipment installed in the microbiology lab.To qualify the microbiologist for the various testing done in the microbiology lab. for preparing documentation. Accountable for QMS related activity. To impart trainings to the subordinated and participate in the training programs.Validation of Microbial Limit Test and BET Validation. Autoclave RequalificationDeft at ensuring compliance to quality measures by maintenance of appropriate documentation/ recordsProficient at driving numerous quality enhancement, process improvement and cost savings initiatives Preparation and review the SOPs and analytical documents such as Specification, Test Procedure, COAs, Validation protocol & Validation reports.Faced USFDA Audits 4 times, MHRA 2 times, ANVISA, MCC, TGA, WHO Audits.Audit Preparation and Document review.GMP documentation.Microbiological Method Updating in LIMS software.