JOBS

Back

QA Operations Specialist – Exothera ( M/F)

January 7th 2021

Univercells has launched a contract development and manufacturing organization (CDMO), Exothera, to support cell and gene therapy developers with process development and production of viral vectors. The company has been created to help alleviate the two most critical challenges manufacturers face in bringing these vital therapies to market: a structural lack of capacity and scarcity of bioprocessing expertise.

Mission Description

  • 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

 

Candidate profile

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)

Offer

For more information please contact to Univercells

Contact Details

Is it appealing to you? Are you a powerful thinker combined with an efficient doer? Apply now!