Dr. Dirk Röhrig Grosse Grof 4 CH-9470 Buchs SG (41) 79 4191350 e-mail: email@example.com Personal Information Marital Status: unmarried Nationality: German Date of birth: 22.03.1963 Place of Birth: Kassel/Germany Work experience 1992 - 1995 Aldrich Chemical Company Steinheim/Germany Development Chemist (development of new items for the Aldrich catalogue) Head of Development and Production of Flavor&Fragrance materials 1995-2002 Sigma Aldrich Fine Chemicals/Fluka Chemical Company Buchs/Switzerland Project manager Fine Chemicals (API Manufacture) European Pharmaceutical sales manager Fine Chemicals 2002- June 2006 July 2006-July 2010 Swissmedic Inspectorate Zurich/Switzerland GMP/GDP-Inspector: Inspection of pharmaceutical manufacturing and retail companies in eastern and central Switzerland on behalf of Swissmedic. Inspection of the entire pharmaceutical quality system (eg CAPA, deviations, change management, materials management). Sigma Aldrich Production GmbH Buchs/Switzerland GMP-Compliance Manager/Quality Assurance. Responsible for qualification & validation of processes and equipment. Internal and external auditing. Risk management. Management of CAPA and nonconformances. Process improvement of existing quality systems (eg change control and deviation procedure, raw materials receipt processes, sampling, testing and release procedures) to achieve FDAcompliance. Preparation of the GMP system for a PAI (pre approval inspection) by FDA. Deputy of the qualified person. August 2010-todate RQM GMP-Consulting GmbH Buchs/Switzerland Company owner and GMP-Consulting expert. Freelancer as GMP/Quality specialist. Recent Project experience: Manager Supplier qualification Development and redesign of the system for supplier qualification. Performance of a GMP GAP analysis and implamentation of a remediation plan. Operative involvement in supplier qualification activities (eg supplier audits). Quality assurance manager (interim) Management of the QA group of a pharmaceutical wholesale organisation, operative day to day business as interim Manager for 6 months Qualification engineer: qualification of pharmaceutical cold storage areas. Transport validation Consultant for the redesign of a qualification and validation system of a pharmaceutical manufacturing organization (vaccine manufacturing) Consultant for the redesign of the system for risk management of a pharmaceutical manufacturing organization (vaccine manufacturing) Operative support in the reduction of open CAPAs of a pharmaceutical manufacturing organization (vaccine manufacturing) Consultant for the FDA compliance of logistic processes (materials receipt and storage) of a pharmaceutical manufacturer Qualified Person (fachtechnisch verantwortliche Person) for the Swiss affiliate of an international pharmaceutical company Education 1969 - 1973 Elementary school Kassel/Germany 1973-1982 Grammar school „Wilhelmsgymnasium“ Kassel/Germany Abitur 1982-1992 University Marburg/Germany Diplom 1987 Ph. D. Chemistry 1991 Languages German (native), English (fluent), Spanish (fluent), French (basic) Private activities Philosophy, Hiking&Biking, Skiing, Carpentry/ Renovation of old furniture Active member in the swiss vegetarian union August – October 2008 Sabbatical/volunteer stay in Guatemala. Work for NGO-Organisation UPROBON. Reforestration and wild life conservation in a cloud forest reserve. Intercultural exchange with native Maya people.