Role DescriptionThis role is instrumental in managing release activities of pharmaceutical and nutritional products in accordance with applicable regulatory and customer requirements (including complying with EU GMP, US FDA 21 CFR and approved Patheon/Thermo Fisher Scientific Policies and Procedures).
Responsibilities- Ensure regulatory obligations of manufacturing and marketing authorizations are fulfilled; - Ensure work is performed according to Quality System requirements; - Review and approval of non-conformities and OOS results; - Promote compliance and adherence to Quality Policies, SOPs, GMPs; - Offering advice / guidance with respect to regulatory expectations and recognized best practice; - Ensure an effective quality management system is operated; - Support Quality System development, promoting the development of a right first time, quality culture; - Demonstrate expertise regarding quality and GMP in interactions with customers, authorities, and other interested parties;
Requirements- At least an undergraduate education (e.g. pharmacy, medicine, veterinary medicine, chemistry, biology, industrial pharmacy or equivalent); - Acknowledged as Qualified Person by the competent authorities or acknowledgement is considered feasible; - Depending on the degree at least 6 months (for NL pharmacists) to 2 years relevant experience (for other degrees); - Quality Assurance or Production or Quality Control / GMP background dealing with the requirements for product manufacturing, packaging, licensing, release and post-market responsibilities;
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.