QUALITY ASSOCIATE

PuursIFarmaceutische industrie

Functieomschrijving

For one of our pharma clients in Puurs we are looking for a QUALITY ASSOCIATE.
 

You will ensure 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.

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.
  • 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.
  • Coordination the implementation of changes per market after Board of Health approval in cooperation with Supply Management members.
Profiel
  • You have a 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.
  • Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy and documentation
  • Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA) is a strong asset
  • Ability to communicate effectively verbally and in writing, good negotiation and influencing skills
  • Insight and understanding of shareholders needs and requirements
  • Dynamic, flexible, enthusiastic and eager to learn
  • Takes initiative and ownership to deliver on time without compromising on quality
  • Ability to work under minimal supervision and in a team (team player as well as team leader, depending on the situation)
  • Fluent in written and spoken English and Dutch
Organisatie- en afdelingomschrijving

Select Projects is part of an international full-service Human Resources organization, Select HR. Select Projects specializes in offering solutions through projectsourcing. From our offices in Belgium and Dubai, we provide support to companies who need expercienced specialists / project staff in several areas. We distinguish ourselves by our good follow-up and service to all our customers and our employees.

 

Aanbod

You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.

Heb je nog vragen?
Marlies Collart Consultant Life Sciences Select Projects +32 3 203 50 80
QUALITY ASSOCIATE Vacature informatie
65737
Engineering Projects I R en D, wetenschap en wetenschappelijk onderzoek
Project sourcing
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