I have about 20 years of experience in the field of analytical research &QC across various dosage forms such as Oral, Liquid, Topical and Parenteral.
I am familiar with handling of regulatory deficiencies from US, EU &ROW market, analytical method development & validation, stability study, laboratory set-up and investigations.
During my career, I got privilege to become part of a team who successfully handled various audits such as MHRA, USFDA, FDA, ISP and NABL.
I am well versed with QMS such as incident investigation, deviations, OOS & OOT.