Senthil Kumar.

Senthil Kumar is a seasoned Quality Assurance and Regulatory Affairs professional with over 25 years of experience in the medical device and OTC drugs manufacturing industry. Having worked on products ranging from condoms and medical gloves to cardiac stents and blood cell separators, Senthil is proficient in spearheading the implementation and maintenance of Quality Management Systems as a Management Representative. He is an expert in planning and scheduling effective maintenance schedules for enhancing quality and regulatory systems, as well as in devising, implementing, monitoring, reviewing and revising Total Documentation Systems as per required Countries Regulation, cGMP,21 CFR 820, ISO 9001:2000, ISO 13485:2003, and MDD/93/42/EEC. Senthil is a qualified Lead Auditor for ISO 9001:2000 and Six Sigma-Green Belt, has demonstrated analytical, problem-solving, and organizational abilities coupled with strong communication and relationship management skills.

Senthil Kumar's professional background includes working as Sr.Manager-QA/RA at BioGenex, Manager-Regulatory Affairs (Medical Device Division) at Larsen & Toubro Limited, and Sr.Manager Quality Assurance at PT Medisafe Technologies. He has studied ACQI, Chartered Quality Institute, London, U.K, Lead Auditor, ISO 9001:2000-Quality Management System at Bureau Veritas Quality International (BVQI), and M.Sc., Chemistry at Bharathidasan University.