Bhavit Sharma
Manager Csv at Continuum India Llp
Based in Chandigarh, India
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Seniority
Manager
Department
Manufacturing & Production
Location
Chandigarh
Industry
Pharmaceutical Manufacturing
Company size
465
Contact information
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b•••••••@continuumindia.com
Phone
5 credits+91 ••• •••• ••••
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Background
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
Decision-makers
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