Personal Information
Organization / Workplace
Chennai Area, India India
Occupation
General Manager - QA, CSV and MR at Navitas Life Sciences
Industry
Technology / Software / Internet
About
• MBA-TQM, M.Sc, PGMLT, IRCA Certified ISO 9001:2015 and ISO 13485 lead auditor with 16+ years of experience with unique blend of qualification and experience in Medical device, Pharmaceutical, Clinical research and Software industries.
• Expertise in implementing ISO13485, ISO 9001, ISO 14971, ISO/TR 14969, IEC62304 ISMS27001,NIST, 20000-ITMS, ISO 15189:2008, and 17025 Quality Management systems.
• Expertise in GxP, 21CFR part11, GAMP, FDA, CFR 820, HIPAA compliance and various statutory regulatory requirements for International business.
• Experience in SDLC and worked as AGILE coach, expertise in risk based validation approach for Software and Instruments with compliance to GAMP-5...
Contact Details
