GDP Quality compliance specialist

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

Do you have knowledge of drug regulations and regulatory guidance of local and leading agencies (EMA, FDA)?

Then we are looking for you!

Vragen? Neem contact op

Elize van Eycken, Account manager

Solliciteer

Over deze functie

In this role, the Quality Compliance Specialist will be responsible to support the maintenance of the customer qualification and supplier screening database as well as providing support for the approval of new customers and suppliers. The Quality Compliance Specialist also will be responsible to develop and maintain a database for export declarations and to perform assessments to the need of those.

The Quality Compliance Specialist will work in cross-functional teams with different departments (manufacturing, external supply, regulatory, site compliance and BT) in order to support the supply of new products from and to new customers and/or countries.

Over jou

  • Master degree in Life sciences (e.g. pharmacist, biomedical sciences, bio-engineer,..)
  • Prior knowledge of local regulatory environment and regulations is highly desirable
  • Knowledge of drug regulations and regulatory guidance of local and leading agencies (EMA, FDA) is a strong asset
  • Fluent in written and spoken English. Knowledge of Dutch and/or French is an advantage.
  • Scientific knowledge and strong analytical skills to make sound quality assessments of documentation requirements
  • Ability to communicate effectively verbally and in writing, good negotiation and influencing skills
  • Understanding of stakeholders 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

Wat wij bieden

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

Samenvatting

  • Vacature nummer: PUB198328
  • Standplaats: Antwerpen
  • Markt: Life sciences
  • Uren per week: 40
  • Branche: Pharmacie
  • Opleidingsniveau: Academic Master
  • Expertisegebied: Project Management & Services
  • Sluitingsdatum: zondag 24 maart 2019
Solliciteer

Vragen? Neem contact op

EE

Elize van Eycken

Account manager Brunel Belgium Mechelen

+32 (0)15 27 33 33

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