Shailesh Bodwade
Executive - IT (Csv) at Gennova Biopharmaceuticals
Based in Pune Division, India
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Seniority
Other
Department
Other
Location
Pune Division
Industry
Biotechnology
Company size
813
Contact information
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s•••••••@gennova.bio
Phone
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Background
About Shailesh Bodwade
Certified CSV & CQV professional with 7+ years in the biopharmaceutical industry, specializing in validation lifecycle documentation, regulatory compliance, and QMS processes. Proficient in GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and SDLC models. Hands-on exposure to equipment / Software qualification, Data Integrity, QMS (Change Control, Deviation, CAPA), Cross-functional collaboration and Audit Readiness.Familiar with JIRA & HP ALM and understanding of cloud computing service models (SaaS, PaaS, IaaS).
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