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Brunel

Site Compliance Network Member

Puurs - België - Life sciences - Pharmacie - Project Management & Services - Academic Master

Brunel | Mechelen | Permanent, Full-time

Published on Jobat.be 7 days ago

The departement you would be employed is responsible for validation and new product registration activities of the assigned products.

You will work in cross-functional teams and collaborate with R&D, global regulatory members (Global Chemistry, Manufacturing & Controls (GCMC)) and the supply department in order to support the introduction of new products in the site.

Site Compliance Network Member

Job description

Your task will be to make sure that the manufacturing and testing practice at the site is appropriately qualified and in compliance with the regulations (GMP, ICH, ..) and with the description in the submitted registration dossiers

To accomplish this:

  • You will perform the quality review for process validation and other product-related validations such as analytical method, filtration, primary packaging and raw material validations. In this quality authority role you will work closely together with different project teams and different departments within Pfizer Puurs as well as with R&D.
  • You will support regulatory submission of the new products by informing site members of regulatory requirements and by providing the project details and the supporting validation data to GCMC. In this regulatory role you work closely together with global regulatory Pfizer members and R&D.
  • You will coordinate the implementation of changes per market after Board of Health approval in cooperation with Supply Management members.

Profile

  • Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..).
  • Minimum 2 years of experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience or interest in validation, regulatory and quality.
  • Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA)
  • Fluent in written and spoken English and Dutch.

Offer

  • An interesting salary package.
  • A dynamic and high-tech life sciences environment.

Interested?

Sissi van den Langenbergh
Mechelen

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Brunel

Blarenberglaan 3, 2800 Mechelen

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27 days left to apply

Characteristics

Offer

  • Permanent
  • Full-time

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