Job opportunities

All vacancies

GLP Quality Associate

Job description

The company is a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics.

To further strengthen our Quality team, we are looking for a motivated GLP Quality Associate with a quality mindset. The GLP Quality Associate will play a role in further build out of R&D quality infrastructure at our client in close collaboration with internal business teams and report to the Head Preclinical Quality & Quality Management.

 

KEY ACCOUNTABILITIES AND RESPONSIBILITIES:

The role is responsible for performing duties related to quality review of GLP-compliant plans and reports, working in close collaboration with the PharmToxBA team and Non Clinical & BioAnalytics Quality team:

  • External Vendor oversight: vendor qualification and routine audits
  • CAPA / deviation / change controls follow-up
  • Review of experiments in electronic Lab Notebook
  • Review of study plans and reports (both internal and external)
  • Drives the implementation of procedures and Work Instructions related to GLP.
  • Supports the maintenance and continuous improvements of the QMS system.
  • Follow-up on the OECD GLP guidelines

The role may also support the Quality team with additional ad hoc project support.

 

DESIRED SKILLS AND EXPERIENCES

  • 5y+ experience in a quality assurance role, dealing with biopharmaceuticals with preferable experience in biological analytical methods
  • Strong knowledge of GLP OECD guidelines
  • Quality attitude; can do mentality
  • Good organization and planning skills
  • Strong communication skills and able to build relationship with business partners and to work effectively together with others
  • Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines
  • Fluent in English – our working language

Contract

Executive search

Experience

Minimum 3 years

Education

Master's Degree

Languages

English

Sector

Pharmaceutical industry

Region

Ghent

Job Type

Full-time

Submit your CV

Please submit your CV through the form below and we will contact you shortly.

How can we help

Drop by for
coffee