Pragnesh Mehta

I am a dynamic seasoned pharmaceutical professional with a proven record of 23 years in leveraging capabilities in API Manufacturing operations, Production Management, Process improvement, Project Management & Qualty Assurance in the API industry with proficiency in managing operations of equipment as per health, safety & equipment manuals & conducting documentation & effective quality Audits. Excellence in working in cGMP environment & facing regulatory inspections by USFDA, EDQM, WHO- GMP, CDSCO, KFDA as well as various customer Audits like Idorsia, Grovet. Proficient at supervising production work & documentation as per API industry regulations & various other regulatory authorities. Expertise in development of innovative processes API & intermediates through cost effective process, scale up for commercial production & assigning years of experience in pharma industries. Production excellence, Green & Brown field project experience, four times USFDA completed, four times EDQM, KFDA & other regulatory Audits successfully completed. Managed cross- functional operations in investigating of Product failure, OOS ,Market complaints, deviations & evaluation of impact/ risk assessment to identify proper root causes & CAPAs. s

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