Seasoned Quality professional with three decades of experience, worked for MNCs as Head - Quality, Compliance and Regulatory Affairs. Successfully handled various regulatory inspections (about 16) from Global regulatory authorities like USFDA, TGA, Health Canada and PMDA. Implemented ISO 9001:2015 as Head Quality and Management representative for 6 years.
During tenure:
(a) Performed globally about 90+ supplier GMP audits for APIs, Formulations and intermediate facilities against the standard ICHQ7, EU GMP (EudraLex), 21CFR and ISO guidelines as per client requirement.
(b) Support in auditing the clients contract manufacturing site for compliance verification and pre-approval before implementation of Technology transfer for drug substance or drug product