Auditor is a seasoned professional with over 10 years of experience in Quality Control (QC), Quality Assurance (QA) management, and as a Quality Director in the pharmaceutical industry. His expertise spans FDA/EU/TGA/PMDA and Chinese GMP compliance, GMP system establishment, and improvement. He has successfully guided companies through GMP inspections by various authorities and provided compliance consultation. Notably, He specializes in data integrity, FDA warning letter resolution, and EU GMP non-compliance report close-out. He has a Bachelor's degree in Pharmaceutical Sciences. Currently, he serves as the QMS Director at Beijing Cowaymed Consulting Inc. and previously held the role of QMS Lead at Beijing Canny Consultancy Inc. His extensive project portfolio includes a wide range of pharmaceutical products and compliance services for API and formulation manufacturing, along with sterile formulation and new workshop construction. He is dedicated to ensuring pharmaceutical quality and compliance.