About

A Quality-oriented professional with over 25 years of experience in Production, Quality Assurance, Quality Control, Quality Engineering, Quality auditor, pharmaceutical regulations, and regulatory audit compliance. The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines. The key competencies include Quality Compliance, Supplier Audit, building systems to encourage compliance with the principles of data integrity, computer system validation, Training, Risk assessment, Facing the audits, preparation, and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post-approval queries raised by regulatory agencies, etc. - Independently handled: Production, Quality assurance, and Quality Control department for more than 13 years. - Audits faced- USFDA (9 times), ANVISA, MHRA, MCC, TGA, WHO audit, EU regulatory (12 times) &Many

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