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Quality Lead GMP

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Introductie

Pivotal role within a large (bio)pharmaceutical company / Being part of a growing company

Het bedrijf / The company

Our client is an international, (bio)pharmaceutical company, and active around the entire globe. The site in the northern Netherlands is a multi-product and multi-client site with development and manufacturing facilities for pharmaceutical products for both clinical trials and commercial production. With state-of-the-art development and manufacturing facilities, they serve both midsize and large pharmaceutical companies. More than half or their clients are midsize businesses. Many of these clients are transforming the way pharmaceuticals are developed and commercialized with a new vision for their business model. Our clients service is their means to make that vision into reality. On the other hand capacity, responsiveness and reliable quality are the reasons for large pharmaceutical companies to trust on our clients expertise. In order to maintain consistent management of their clinical and commercial contract manufacturing projects, they are looking for a Quality Lead GMP.

De functie / The role

In this role, you are responsible for the final disposition to customers of bulk drug substances and for managing all activities to enable this disposition in an efficient and GMP compliant way according the agreements made with the project manager, the client and according to regulatory expectations.
You propose and implement improvements related to quality and compliance and you advise to project organization and customers on all relevant GMP matters and assure appropriate GMP level of project activities.
You serve as a quality advisor for investigations and recommend actions to ensure continued compliance and avoid recurrence. Furthermore you are responsible for the review and approval of GMP documents associated to the product in compliance with local and corporate SOPs and applicable legislation. Ofcourse you approve investigations assuring that they are complete, accurate, technically justified with the required documented evidence including risk assessment. You evaluate and approve changes associated with the product. You plan, perform and monitor in collaboration with the Project Manager QA activities within the project to ensure results are according the agreement and regulatory expectations. Last but not least you provide assistance and guidance with regard to the Quality Systems to other departments and you propose and implement improvements to these systems. You work in a team with 4 other Quality Leads GMP.


Het profiel / Your profile

o academic level in Life Sciences for instance Biochemistry, Microbiology, Pharmacy, Biotechnology, or Pharmacology.
o minimum of 5 years relevant experience in a (bio)pharmaceutical company;
o experience with project management;
o combination of experience and educational level should be sufficient to act as the person responsible for release of bulk pharmaceutical products
o strong communicator who adopts a logical approach and is able to interact effectively with project teams and clients
o strong skills in: planning and organization, decisiveness, problem analysis, able to build support
o excellent communication and presentation skills in English. Dutch is preferred


Het aanbod / The offer

o core position within an ambitious and growing company
o part of a highly talented team
o highly responsible and multi-interface position
o attractive benefits package


Reactie / Reaction

Interested? Please send your resume and motivational letter by Email, with reference to WS/19-058-DD to Anneke den Hartog: info@derksenderks.nl.
For further information, please call Anneke den Hartog at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

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.


Gegevens

Werkgever:
Derks & Derks
Vacaturesteller:

Standplaats:
Northern Netherlands

Geplaatst op FMF: 23 augustus 2019

Branche: Farma & Biotech
Functie: QA / regulatory
Opleidingsniveau: WO/academisch / MSc
Werkervaring: 5-10 jaar