Wellen, Flemish Region, Belgium
Experienced Quality Assurance Manager with a demonstrated history of working in the medical device industry. Responsabel for Supply Chain and Supplier Selection and evaluation. Skilled in Pharmaceutics, Management, Validation, GMP, and Quality Assurance. Strong operations professional with a Master's degree focused in Environmental Engineering Technology/Environmental Technology and s PhD in Genetical Engineering.
Responsible for registration of (generic) plant protection products according to EU regulation 91/414. Coordination of necessary studies to obtain registration, compiling registration dossier. Keep being informed about European requirements and member state specific requirements for placing on the market of plant protection products. Maintaining of registrations, answering questions of authorities
Managing registration of phytopharmaceuticals under current Directive 91/414 and new legislation 1107/2009. Data gap analysis and project/trial planning. Trial coordination. Risk evaluations. Dossier writing