Curriculum vitae for
Anders Clausen, M.Sc. (pharm.)
2008-
Owner of c-Compliance.
2006-2008
Director of Quality Assurance, Rheoscience A/S. Responsible for implementation of an ICH GCP compliant Quality System, performed audits (GLP and GMP) of sub suppliers (production and handling of drug product, IT, laboratories) participated in GCP audits (CROs and clinical site), responsible of any advice regarding handling of drug products, project manager on implementation of a 21CFR11 compliant Documentum IT system.
2004-2006
Principal Scientist, QA Site Gentofte, Drug Product & Support, Novo Nordisk. QA coordinator in rebuilding of a filling factory and implementation of a new freeze dryer, QA of qualification of production equipment including IT systems (change requests and handling of non conformities).
2001-2004
Principal Scientist, QA Site Gentofte, Drug Products, Novo Nordisk. Responsible of release of NovoSeven finished goods and packaging orders, acted as Qualified Person (QP), handling of non conformities, failure investigations and change requests, QA of validation of process changes, participating in FDA inspections, management responsibility of 5 QA assistants.
1999-2001
Principal Scientist, Laboratory & Process Development QA, Novo Nordisk, QA responsible of analytical development laboratories.
1999-2006
Lead auditor spending 25 % of full time performing GMP and ISO audits in and outside Novo Nordisk. Performed audits in Denmark, Europe, Australia, Asia, US, South America within a variety of departments/companies: Laboratories, subsidiaries, production of API, finished goods, packaging departments, primary packaging materials, development units, QA departments etc.
1997-1999
Principal Scientist, Staff to the Vice President of Development Quality Assurance, Novo Nordisk. Responsible of internal IT systems, implementation of other systems, Vice precident's representative in working parties with the Development organisation in Novo Nordisk, Passed ISO 9001 lead auditor examination in 1997.
1995-1997
Chemist, Development Quality Assurance, Laboratory QA, Novo Nordisk. Responsible of QA of Development laboratories (pharmaceutical formulation and analytical labs.), chairman og group preparing general laboratory procedures for all Novo Nordisk analytical laboratories.
1994-1995
"GMP-chemist" Analytical Chemical Laboratory, Raw Material Control, Novo Nordisk. Responsible of validation of analytical methods and equipment .
1985-1994
Chemist, Analytical Chemical Laboratory, Raw Material Control, Novo Industri A/S. Responsible of preparation of analytical procedures according to the United States Pharmacopoeia and the European Pharmacopoeia, preparation of SOPs in compliance with US and EU laboratory GMP, implementation of new equipment, management responsibility of 7 laboratory technicians.
1983-1984
Assistant teacher, introductory and analytical chemistry, the Danish University of Pharmaceutical Sciences. Pharmacist at Lyngby Svane Apotek.
1983
Finalised studies at The Danish University of Pharmaceutical Sciences M. Sc. (pharm.)