Auditor is a seasoned GMP Quality Assurance and Regulatory Affairs Consultant with 23 years of extensive experience in the pharmaceutical industry. He specializes in leading the development, execution, and management of Quality Management Systems and conducting various GLP and GMP audits globally. He has completed over 600 audits for standards such as 21CFR Part 210, 211, 111, 820, ICH Q7, ISO13485, and others. His expertise includes API product development, interpreting mass and IR data for FDA submissions, and providing QA services. He has conducted audits and provided consultancy services in numerous countries worldwide, including the USA, Netherlands, Belgium, France, Italy, and others. He holds certifications in ISO 13485:2016 and ISO 9001:2015 Lead Auditor from British Standard Institution (BSI) and has completed various professional certifications and training programs in regulatory affairs and quality management. His extensive experience, leadership skills, and technical expertise make him a valuable asset in ensuring compliance and quality in the pharmaceutical industry.