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QC Raw material release specialist (H/F/X)

April 13th 2021

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 Officer is responsible to maintain the Sterility Assurance system aspects.

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

The QA Sterility Assurance Officer is responsible to maintain the following quality systems. He/She :

  • Supports all Sterility assurance aspects in the project related matters in the Catalent organization.
  • Provides QA Validation support of change control process to ensure execution are compliant with internal policies and procedures for Sterility Assurance aspects.
  • Ensures the review, challenge and approval, in compliance with GMP, Deviation, CAPA, Change Control, Risk Analysis quality system documents.
  • Reviews and approves the protocols and reports liked with the Sterility assurance emitted to give the assurance they are compliance with the current regulation. (Environmental Monitoring, Media Simulation process)
  • Participates to the classification and declassification activities
  • Realizes periodical check in production and oversight on sterility assurance activities

Candidate profile

  • Good communication skills
  • Rigorous, conscientious, flexible and honest, Quality mind, Ownership
  • Willing to bring new challenges
  • Fluency in French and good speaking, reading comprehension and writing skills in English
  • Experience in a  biopharmaceutical company and knowledge of quality tools is a must
  • Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

 

Offer

  • Full-time position (40h/week).
  • 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

To apply for this job, please send your application on the following link : Catalent