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QA Operations Engineer (H/F/X)

October 4th 2022

Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.

Mission Description

  • QA Operations Engineer is an active member of QA Operations team. This team is responsible for the direct quality oversight of GMP manufacturing activities, including material management in the production of clinical and commercial cell therapies
  • Deputy of the QA Operations Lead Engineer.
  • Performs QA on the floor
  • Performs Batch Record Review, QC raw data review and compiles all data for the submission to the QP
  • Reviews Deviations, CAPA, Risk Assessment, Change Control
  • Actively works with the team to adequately resolve problems
  • Actively works the team to evaluate risks assessments to support adequate decision making
  • Escalates problems and propose solutions in a timely manner
  • Reviews and approves documentation related to batch start and batch disposition in time

Candidate profile

  • Graduate degree in bioengineering, (bio)chemical engineering, biotechnology or other science  related field
  • 3-5  years of experience in the biopharmaceutical industry. Experience in both Manufacturing and QA roles highly preferred
  • Experience in the ATMP industry is a plus
  • Experience with Batch Record Review, Deviation/CAPA and Change Control
  • Fluent in French, good command of English is highly preferred.
  • Good communication and collaboration skills
  • A solution-oriented approach to complex situations
  • Strong critical thinking skills
  • Able to work in a fast-paced and dynamic environment

Offer

  • Full-time position (40h/week)
  • An indeterminate contract, meal vouchers, health&group insurances
  • The opportunity to take part in a growing dynamic biotech company
  • A human-sized working environment with a convivial atmosphere

Contact Details

https://careers.catalent.com/us/en/job/0069176/QA-Operations-Engineer