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Senior Qualified Person (QP)

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Challenging senior position within a new Quality team

Het bedrijf / The company

Our client is a leading biotech organisation that discovers, develops, and delivers therapies to improve the lives of patients. They offer therapies for neurological diseases, globally, through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. The atmosphere is very open and accessible. This is also reflected in the mutual cooperation, along with their key focus on professionalism and a drive to accomplish the best results for the society. For their new Global External Quality team there are searching for a Senior Delegated Qualified Person (QP) to join their office near Amsterdam.

De functie / The role

As Senior Delegated Qualified Person (QP) you will act as back up of the current manager. In his absence, you will be the first point of contact for the organization and you will coordinate the team activities. The Global External Quality team is responsible for certifying the finished products of the organization within the EU. Also, they ensure that the finished medicinal product batches are manufactured compliant with GMP, the Manufacturing Authorisation (MIA) and the Marketing Authorisations (MA). In addition they ensure compliance with both national and international authority regulations, as well as internal regulations in order to ensure quality assurance. You will review and approve product quality reviews (PQR/APR). You have a thorough understanding of quality management systems, pharmaceutical law, manufacturing medicinal products and its supply chain. All in all, a challenging position in an enterprising and innovative organization characterized by their personal approach.

Het profiel / Your profile

• • M.Sc. in (or similar to) Industrial Pharmaceutical Science.
• More than 5 years of relevant experience required (in an FDA and EMA approved pharmaceutical environment).
• Experience as QP within either biotech or pharmaceutical industry.
• Good mathematical and statistical skills, as well as leadership skills.
• Able to act decisively, work well under pressure and make confident judgements.
• Good communication skills in English and preferably in Dutch (verbal, reading and writing).

Het aanbod / The offer

• Challenging position within an innovative biopharmaceutical organization.
• Small team with a global focus on Quality.
• Healthy pipeline of new innovative products.
• Very attractive employment conditions package.

Reactie / Reaction

Interested? Please send your resume and motivational letter by e-mail, with reference to WS/20-044-FMF, to Tim van Loon : info@derksenderks.nl.
For further information, please call Tim van Loon at number +31 (0)33 472 80 87.

Tenslotte ..... / Finally ....

Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

Uw referentie aan www.fmfvacatures.nl wordt gewaardeerd.
Your referral to www.fmfvacatures.nl is appreciated.



Derks & Derks

Geplaatst op FMF: 13 augustus 2020

Branche: Farma & Biotech, Medical, Healthcare
Functie: QA / regulatory
Vacatures Internationaal: Internationaal
Opleidingsniveau: WO/academisch / MSc, PhD
Werkervaring: 5-10 jaar, > 10 jaar