PCS Niehörster

Dr. Marcus Niehörster

Dr. Marcus

has been working as an auditor, reviewer and consultant for authorities and pharmaceutical companies worldwide for more than 25 years. He studied biochemistry at the Universities of Tübingen and Munich and is a graduate of the graduate program "Biochemical Pharmacology" of the State of Baden-Württemberg and received the academic degree of Ph.D. at the University of Konstanz. His professional experience includes blood product manufacturing and laboratory management for chemical-physical testing of active pharmaceutical ingredients and drugs. He is professionally qualified as a Senior GMP Compliance Expert and as a Senior GMP Auditor and has been acting as a GMP Subject Matter Expert of the Swiss Accreditation Service SAS for more than 15 years as well as an expert witness in judicial and extrajudicial disputes. His auditing expertise includes over 250 audits of drug manufacturers, starting material suppliers, contract laboratories and biotech companies. His resume also includes project management and execution of numerous global drug and API GMP compliance projects.