QUALITY VALIDATION ENGINEER

PuursIFarmaceutische industrie

Functieomschrijving

The Regulatory and Validation Department located in Puurs  is seeking a dynamic Validation and Regulatory Quality Associate to join our team..
 
In this role you will be responsible for validation and product registration activities of the assigned products.
You will work in cross-functional teams with different Puurs departments (manufacturing, labs, ..) and collaborate with R&D, global regulatory colleagues (Global Chemistry, Manufacturing & Controls (GCMC)) and the supply department in order to support the introduction of new products in the site.

Are you seeking to work with innovative products, in an exciting and fast evolving environment? Join theteam!


MAIN RESPONSIBILITIES

You 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. 

To accomplish the above:

  • You 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 support regulatory submissions of the products by informing site colleagues 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 colleagues and R&D.
  • You coordinate the implementation of changes per market after Board of Health approval in cooperation with Supply Management colleagues.
Profiel
  • 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.

For one of our pharma clients in Puurs we are looking for a QUALITY VALIDATION ENGINEER

 

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?
Aartje Huybrechts Select Projects +32 3 612 22 92
QUALITY VALIDATION ENGINEER Vacature informatie
64606
Engineering / Techniek
Project sourcing
40
Wat is mijn reistijd?

Solliciteren bij Select Projects

Je solliciteert op onze website?

  • Je solliciteert bij Select Projects
  •  
  • Je ontvangt doorgaans binnen 1 werkdag bericht
  •  
  • We maken kennis in een (telefonisch) gesprek
  •  
  • Is er een klik dan doen we je een voorstel
  •  
  • We gaan samen. werken. Welkom bij Select Projects
  •  
  • Je coach biedt persoonlijke carrière begeleiding
  •  
  • Nieuwe projecten en ervaringen houden je scherp
Meer info over onze sollicitatieprocedure