Srikanth Varma Kc
Lead Auditor - Global Audit & Due Diligence at Abbott
Based in Mumbai, India
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Seniority
Manager
Department
Other
Location
Mumbai
Industry
Hospitals and Health Care
Company size
166K
Contact information
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s•••••••@abbott.com
Phone
5 credits+91 ••• •••• ••••
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Background
About Srikanth Varma Kc
An accomplished Quality & Compliance professional with 19 years of experience in Pharmaceutical & Medical devices / Drug Delivery systems Working as Lead Auditor in Abbott Global audit team. Performing Quality audits of APIs, Finished Oral dose forms, Injectables, Medical devices etc across the globe. IRCA Certified Lead Auditor QMS ISO 13485:2016 Profound knowledge of GMP aspects of pharmaceutical and medical device industry. Performed Quality Audits ( Due deligance & Qualification audits) for APIs, Formulations, Excipients, CMOs, CROs, and Primary packing containers/ materials. Faced USFDA, EMA, TGA, CANADA, PMDA and other emerging market GMP audits. Experience in working for technical documents preparation and review of Biologics/Biosimilar products filings in US, EU, Japan and other markets for combination products and part of regulatory audits. 510K and CE mark filing and approval for devices. Expert in developing, implementing and inspecting policies, standards and procedures for scientific work and technical work in the department or project technical projects
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