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Sivakumar V

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Biography V. Siva Kumar Pharmaceutical Quality Professional Responsible for Quality Systems implementation, Gap Assessment, Inspection Readiness and Audits Management including Remediation activities. Responsible for Head of Quality Operations at Worldwide Research and Development activities of Pfizer, Chennai since Feb 2019 and was working with Mylan as Associate Director for Corporate Quality operations in Aseptic operations about 6 Years and with Micro Labs in the capacity of General Manager -Quality Assurance for site Quality functions about 3 years. Siva Kumar was appointed as a Senior Manager – GMP Auditing & Testing services for Verification Programs at United States Pharmacopeia (USP) in the beginning of 2007. Previously, Siva Kumar served as “Quality Assurance Auditor” for Perrigo Company. At Perrigo, he was responsible for GMP Auditing in Suppliers of Perrigo in European countries, China and India, including the developing and maintenance of Quality Systems in Perrigo operations in India. Well-experienced in conducting GMP audits in APIs, Dosage forms, Excipients/Dietary supplements and contract manufacturing and testing facilities for quality system assessments for preparing for EU and FDA inspections. Prior to this, Siva Kumar worked for reputed pharma companies in India like Orchid Pharma, Dr.Reddy’s Labs, Cipla and Themis Medicare where he held several roles in Quality Assurance functions. Handled successfully many USFDA, TGA, EDQM and WHO-GMP regulatory audits. Siva Kumar is a Certified Quality Auditor from American Society for Quality (ASQ CQA) and Trained ICH Q7 Auditor from European Compliance Academy (ECA). He also involves on-site GMP training and a frequent speaker / trainer at a variety of conferences organized in India and China. He is a senior member of American Society for Quality (ASQ). Siva Kumar holds a Master Degree in Organic Chemistry and M.B.A in Labour Law. Contact Details E-mail: [email protected]; Mobile: 0091-8105416178

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