Experienced, AGM with a demonstrated history of working in the pharmaceutical industry. Skilled in QA team handling including IPQA & documentation. Experience in Quality Management System & its implementation in plant, Equipment and Utility Qualification, Cleaning Validation, Investigations using statistical tools, Corrective and Preventive Action (CAPA), Rich External Auditing experience etc. Regulatory applications experience related to FDA, BRC-GS (Issue 9), FSMA, ISO 9001, ISO 22000, Halal, Kosher, FSSAI renewals. Faced audits of MHRA, WHO-GMP, ISO, customer audits, Halal authorities, Kosher authorities etc. Strong quality assurance professional with B. Pharmacy, MBA (Operations) and PG diploma in Regulatory Affairs.