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QA Sterility Assurance Specalist (H/F/X)

September 27th 2022

Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.

Mission Description

The QA Sterility Assurance is responsible to implement and maintain the sterility assurance system aspects.

The QA Sterility Assurance is an active member of QA Validation team.

The QA Sterility Assurance Specialist is responsible to implement and maintain the following quality systems.

Your main responsibilities will be :

  • Take in charge of all Sterility assurance aspects in the project related matters in the Catalent organization.
  • Update the SOPs linked with Environmental monitoring and Sterility assurance aspect for initial use and maintaining the validated status
  • Provide QA Validation support of change control process to ensure execution are compliant with internal policies and procedures for Sterility Assurance aspects.
  • Ensure the review, challenge and approval, in compliance with GMP, Deviation, CAPA, Change Control, Risk Analysis quality system documents.
  • Review and approve the protocols and report liked with the Sterility assurance emitted to give the assurance they are compliance with the current regulation. (Environmental Monitoring, Media Simulation process)
  • Update and take appropriate measures to control the risks associated with Sterility assurance.
  • Ensure the good realization on declassification and classification activities
  • Be Subject Matter Expert covering QA questions, related to Sterility assurance aspects, by customers or internal teams.
  • Hands-on approach, presence in the field, ops.

Candidate profile

  • Experience of minimum 3-5 years in Quality Assurance, preferably in a  biopharmaceutical company
  • Expert in GMP environment
  • Experienced in aseptic environment
  • Good knowledge of quality tools ( cGMP, Well acquainted with Change control/ deviation and market compliance management system)
  • Fluent in French. Good reading comprehension and writing skills in English
  • Good communication skills
  • Rigorous, conscientious, flexible and honest, Quality mind, Ownership
  • Willing to bring new challenges
  • Likes being in the field

Offer

  • Full-time position (40h/week).
  • Group & Health Insurance, Meal Vouchers.
  • An indeterminate contract.
  • 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/0070848/QA-Sterility-Assurance-Specialist