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Attendeer FMF hierop
Diverse, international, responsible job for an ambitious QA professional
Het bedrijf / The company
Our global client manufactures and markets high-quality drugs in a diversity of fields. With a diverse portfolio of products and solutions, they are continuously providing patient healthcare solutions. They have built a promising pipeline centered around their core therapeutic areas. Through continuous investment in their research and development, marketing and business development, they keep growing their medicines business. Innovation is at the core of this company, with the aim of improving health and contributing to better, healthier lives. We are currently looking for a QP to manage the Quality Release team.
De functie / The role
As QP you will be responsible for the Quality Release activities in order to ensure products are efficiently distributed into The Netherlands and other European countries. Also including the release of clinical supplies by meeting the companies, regional, local standards and customer needs. In addition, you will manage the Quality Release team as relevant. The main tasks consist out of ensuring the GMP & GDP compliance with the national standards and ensuring training where needed and creating, maintaining and distribute SOP"s and working instructions. If applicable, you will ensure a system is in place to manage and review Product Quality Reviews for local products and attend to European monthly quality councils. In addition, your focus will be on market release (batch release and transport condition documentation), QP certification (according to GMP, including clinical supplies for R&D), distribution (ensuring GDP compliance, traceability of finished and returned products, etc.), complaints and recalls (ensuring quality complaints are registered and liaise with the manufacturing site or pharmacovigilance for corrective actions), change control, deviations and CAPA"s and monitoring and maintaining the list of suppliers/customers and 3rd party service providers. In this position you will report to the Director Quality.
Het profiel / Your profile
o masters" degree in Pharmacy, Medicines, Biology or an equivalent combination of education and experience to the functional role
o minimum of 2 years" experience as a QP in a pharmaceutical company or importer/distributor
o experience with IMP is preferred
o in-depth knowledge of Quality Compliance within the pharmaceutical industry and working knowledge of pharmaceutical operations
o in-depth understanding of cGMP & GxP's regulations
o experience with development and implementation of Quality Systems and application of risk assessment tools
o result-driven, good managerial skills, stakeholder manager, problem solving, independent, stress tolerant, flexible, team player, strong communicator
o excellent in Dutch and English (oral and written skills)
Het aanbod / The offer
o combination of QP and management responsibilities
o international environment
o working for a company with a diverse and interesting product portfolio
o part of a highly motivated, committed and professional team
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-142-DD, to Sandra van Putten: firstname.lastname@example.org.
For further information, please call Sandra at number +31 (0)33 472 80 87.