Lausanne, Vaud, Switzerland
Quality Assurance professional with over 25 years experience in research and development, manufacturing and distribution, operational and corporate roles, developing and implementing GxP Quality Standards, competitive benchmarking, regulatory inspection management, international project management, establishment of QMS and team supervision. In-depth QA and GMP experience in primary/secondary API processing, healthcare products and medical devices. PhD in Bioorganic chemistry. Specialties: In-depth knowledge of both conventional pharmaceutical manufacture and biotechnology including sterile processing. Comprehensive experience in both daily and strategic management of all aspects of Quality Assurance and GMP. Development and implementation of comprehensive corporate GxP Quality Standards leading to successful inspection track record and assuring business continuity. Successful development and implementation of the Quality Management System of newly created structures. Compliance trouble shooting, auditing and enhancement following major compliance shortcomings or Quality issues.