Sujit Wazarkar Email & Phone Number

Hello! 👋 I'm Sujit.I am an experienced IT Validation Engineer (CSV Lead) at Ascensia Diabetes Care (formerly Bayer), bringing over 12 years of expertise in Computer System Validation (CSV) lifecycle, Agile implementation in the Life Sciences industry, and a solid track record in regulatory compliance and software validation.My Core Competencies:CSV Lifecycle Management: Successfully led and completed numerous CSV projects, showcasing proficiency in coordinating with suppliers and cross-functional teams.Agile Implementation in Life Sciences: I specialize in implementing Agile methodologies tailored for the Life Sciences, promoting efficiency and adaptability.Regulatory Compliance: With an in-depth understanding of Pharma regulatory requirements, including 21 CFR Part 11, EU Annex 11, GAMP 5, and CSA guidelines, I ensure robust compliance standards.Vendor Release Management: Proven success in effectively managing vendor releases to enhance system capabilities.Cloud Computing: Proficient in leveraging cloud computing for streamlined operations and enhanced data management.Supplier Assessment: Actively involved in supplier audits and the preparation of service level agreements, ensuring a robust supplier relationship.DevOps for Agile: Skillful application of DevOps practices in Agile methodologies, contributing to continuous improvement and innovation.Feel free to connect for discussions on industry insights, potential opportunities, or to explore how we can drive excellence in CSV and beyond. Let's collaborate and create a positive impact together! 👋🚀

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  Amravati University

  Pharmaceutics