With 23 years of experience in GMP quality assurance within the pharmaceutical industry, I am a seasoned professional specializing in Quality Management Systems and conducting GLP and GMP audits globally. My expertise covers various regulatory compliance standards, including 21 CFR Part 210, 211, ICH Q7, ISO13485, and more. I have a strong track record in managing global audit plans, regulatory inspections, and offering quality assurance services. Throughout my career, I've conducted audits in multiple countries, including the USA, Netherlands, Belgium, and France, covering areas such as manufacturing, analytical laboratories, and formulation development. My qualifications include an MBA in International Business Management and certifications as a Lead Auditor in ISO 13485 and ISO 9001:2015, among others. I've played key roles in implementing quality systems, regulatory compliance, and project management, making me a valuable asset in the pharmaceutical industry.