Sameer Shete Email & Phone Number

Master in Microbiology,work specialization in Quality Assurance, experience in Bacterial,Viral and Polysaccharides vaccines and Recombinant DNA product manufacturing review, Cold chain monitoring and documentation during dispatchExposure of Quality Assurance Operation, Systems, PQR Preparation and cGMP compliance. Experience and knowledge of audit/compliance/ regulations of various regulatory audits like USFDA, MHRA, ANVISA, EU GMP, WHO (GENEVA), MED SAFE etc.Working experience with Highly motivated attitude and expertise in Biological and Pharmaceutical areas.Good managerial skills, a good team player, Planning & Execution skills, good experience on operational problem solving and Improvement of Quality system with focus on cGMP Auditing, Quality System , Validations .QUALITY SYSTEM• Deviations Management(Risk Assessment) /Change control management.• CAPA, • Investigations, • Risk Assessment of fill finish/Bulk, • Product Quality Review, • Market Complaints, • Product Recall, • Batch Record Review, • Product Disposition/Release, • Quality System SOP preparation and review, • Technology Transfer,• Validation Protocols and Reports • cGMP TrainingValidation and QualificationHaving a knowledge of Aseptic simulation , Knows Developmental activity of New vaccine

Listed skills include Microsoft Excel, Microsoft Office, Fda, Gmp, and 26 others.