Representative Profile of our GMP Compliance Auditor
Our GMP expert has more than 40 years of experience in managing Quality functions for major Pharmaceutical companies in India. Out of the 40 years, the expert was engaged for 25 years in ‘senior management’ roles.
- He is well versed with US FDA, EU GMP requirements and the Indian Drug Regulations. He is associated with several EU and FDA approved pharmaceutical organizations both in India and overseas. He is experienced in implementation of Quality Management System for manufacturing, warehousing and distribution of medicinal products
- He took a lead role in several successful regulatory (US FDA, TGA, WHO, EDQM, MHRA, SA MCA) inspections of the companies where he worked.
- He has audited several API, Formulations, Excipients and intermediates manufacturing units in India and in other countries (US region, European countries, Malta, China and Korea).
His Core Competence:
- Quality Assurance in aseptic and non-aseptic manufacturing operations
- Third Party Contractor Quality Management
- Quality and GMP compliance in API manufacture (ensuring ICH Q7 compliance)
- Technology Transfer (spearheaded several technology and product transfers)
- Process and Analytical Validation
- Six Sigma and Operational Excellence support (Certified Green Belt)
- GMP Training
- GMP Documentation
- Regulatory Compliance
- Quality Risk Assessment (managed Risk Management and Compliance Board in India for a multinational UK headquarter pharma major).
Other key personnel include: