Geneva Area, Switzerland
Owner, Managing Director, International Compliance Services Maven
Pharmaceuticals
Experience
International Compliance Services Maven October 2010 - Present
International Complaince Services July 1998 - Present
Sandoz Pharmaceuticals March 2010 - October 2010
Merck KGaA January 2007 - March 2009
Serono International July 2003 - December 2007
Elan February 2001 - March 2003
Fisons 1992 - 1995
Skills
FDA, Market Access, Regulatory Affairs, Change Control, 21 CFR Part 11, Analytical Chemistry, Aseptic Processing, Sop, Clinical Trials, Regulatory Submissions, Validation, CRO, Quality Assurance, Regulatory Requirements, Drug Development, GxP, Pharmacovigilance, Technology Transfer, LIMS, Pharmaceutics, Quality Auditing, Lifesciences, Medical Devices, Biotechnology, Oncology, GLP, CTMS, CAPA, Biopharmaceuticals, Contract Manufacturing, Chromatography, Quality Control, GMP, V&V, Quality Management, Pharmaceutical Industry, GAMP, Trackwise, Drug Discovery, Computer System..., Quality System, Commercialization, R&D, Formulation, GCP, IND, Vaccines, ISO 13485, Cleaning Validation, Clinical Development