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Senior Manager QAE Artwork
Temporary position in a divers role for Quality with a focus on artwork and manufacturing
Het bedrijf / The company
Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is located in Leiden but has tight lines all around the world. The organisation is looking for support for the Pharmacovigilance department. They would like to come in contact with an experienced and enthusiastic Manager QAE Artwork.
De functie / The role
In the role of Manager QAE your responsibility is to realise high quality consistency of products and processes within Supply Chain and Contract Manufacturing and contribute to QA support for the related activities. You will monitor the quality risk for Quality Assurance of marketed products and processes in terms of GMP and GDP and you will lead and supervise Quality Assurance of such Products and processes. You develop and maintain the Quality system for Artwork Management, Master Data Management and Supply Chain Change management for the EU region and support the related management review processes. You also develop and maintain the Supply Chain Change Control processes and coordinate and cooperate Quality Assurance Activities with Supply Chain & Contract Manufacturing and Affiliates communicating with QA and other regions. You stabilise relationships with stakeholders as with the European manufacturing sites. Furthermore, you collect new developments in external Quality Assurance requirements, EMEA, ICH etc. and give the training to relevant departments. You will report to the director of QA and you will work closely with the directors and manager on the European manufacturing sites in QA, technology of contract manufacturers.
Het profiel / Your profile
o a science-based degree (pharmacy preferred)
o relevant external pharmaceutical (professional) training
o comprehensive GMP experience within a manufacturing facility and / or regional QA role and proven GxP audit experience
o good organizational, coordination, negotiation, presentation and communications skills
o contributing to global impact projects and/or previous experience leading small QA teams
o fluency in written and spoken business English
o understanding of European regulatory environment
o precise, rigorous and reliable with an analytical mind and attention to detail
o anticipation and sound decision-making skills
o knowledge of IT systems compliance to GxP
o full availability during business hours to respond to significant quality issues including flexibility for significant issues which may arise from time to time outside normal working day
Het aanbod / The offer
o a diverse job in Pharmacovigilance at a pharmaceutical company
o an interesting job because of the international contacts
o a temporary contract for 6 months, with the possibility to extent
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-032-FMF, to Sandra van Putten: firstname.lastname@example.org. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.