QA Operations Specialist – Exothera

Based in Jumet you will join a QA Operations team under construction to contribute to the start-up and operation of our brand new Exothera pharmaceutical manufacturing site for viral vectors. 

As QA Operations Specialist you will be part of the QA department and you will collaborate with the manufacturing and supply chain teams. You will act as the link between the manufacturing operations and the quality system to safeguard the quality, safety and efficacy of pharmaceutical products and the cGMP conditions of the manufacturing processes and area. You are the on-the-shopfloor QA partner.

RESPONSIBILITIES

  • Perform technical review of cGMP documentation for completeness and compliance to cGMPs
  • Provide advice and counsel on cGMP and related quality assurance issues (deviations, out-of-specification) and changes (change control)
  • Provide on the floor QA support and perform QA Operations activities (batch record review and issuance, line clearance, logbook and documentation review, aseptic processing oversight, etc)
  • Ensure incoming materials are appropriate, released for use, and correctly dispensed

REQUIREMENTS / QUALIFICATIONS

We are looking for new colleagues with these required skills to support our ambitious goals:

  • MSc or equivalent in scientific discipline, engineering, or related discipline with the required skills, knowledge, and abilities that are typically acquired through experience in a biopharmaceutical manufacturing environment with cell culture activities.
  • You bring 2 – 5 years of hands-on GMP experience in pharmaceutical QA, QC, MS&T, or sterile manufacturing environment
  • You have experience with single-use processes and equipment
  • You have experience or are highly interested in digital QA approach
  • You are a problem solver (and master quality investigation techniques)
  • You get energized by Teamwork
  • You can define pragmatic solutions within the pharmaceutical regulatory framework
  • You are fluent in French and English (both oral and written)