Bhavit Sharma

About Bhavit Sharma

I have 15 years of experience in Pharmaceutical manufacturing industry and CRO. I am IRCA certified ISO 9001 : 2015 lead Auditor and has six sigma green belt certification. I have exposure to different areas of Validation and Quality Assurance and got insight and understanding of handling regulatory audits, CSV and GMP requirement of USFDA, MHRA, etc. I have expertise in designing and implementation of quality systems, Validations & Qualifications (Sterile and Non-sterile), Trainings and Quality risk management studies. I have experience of more than 17 Regulatory agencies and many customer audits. Skills: Team Leadership · Cross-functional Coordination · ISO 9001: 2015 LA · GAMP 5 · U.S. Title 21 CFR Part 11 Regulation · EU Annex 11 · Computer System Validation · Databases · Learning Management Systems · Software Development Life Cycle (SDLC) · Project Management · Project Management · Equipment Qualification · Smartsheets · Equipment Qualification · Six Sigma Green belt

Experience

1. Manager Csv

   Continuum India Llp

   Sep 2021 — Present · Chandigarh, IN

   1.Defining, implementing, maintaining and improving CSV related procedures and process in line with regulatory requirements. 2.Ensuring and tracking the validation status of computersised systems thorugh out its life cycle. Ensuring decomissioning of computerised systems in line with GAMP 5 requirements. Conducting supplier audits to ensure that QMS is in place. Planning, scheduling, implementation, and managing CSV projects for SaaS and PaaS…