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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 QC RM release specialist main role is to define the testing strategy and to release the raw materials used in the GMP operations:

  • Establish, draft and follow the material qualification plan for Catalent products.
  • Define the clinical phase and the list of material for RM, SM and CP
  • Collecting the documentations for material: CoA, CoO, CoC, PIF
  • Define the requirement for the material: compare and analyze the Guidelines
  • Supplier certificates, documentation and informations are assessed against the requirements
  • Define the mitigation plan
  • Propose alternatives/mitigation/justification
  • Draft, review and follow up the material qualification plan
  • Follow-up pending actions.
  • Internal specific project meeting
  • Contact suppliers in order to obtain quality information
  • Write the material qualification plan and risk analysis for each raw material
  • Write raw materials specifications
  • Define the sampling and the testing strategy
  • Contact subcontractor’s laboratory for raw materials testing if applicable
  • Follow-up and review subcontractors’ raw materials testing
  • Release raw materials for GMP use in due time according to operations’ needs
  • Follow up pharmaceutical regulatory requirements, and pharmacopea
  • Perform his/her duties and document his/her work according to Catalent’s current procedures and GMP rules
  • Initiate or review deviations, OOS, CHC and lead necessary investigation. Implement CAPA.
  • Is back-up or for RM sampling activities

Candidate profile

  • Bachelor’s degree or higher in biology, biomedical sciences, biochemistry, clinical chemistry
  • At least 2 years experience in cGMP environment.
  • At least A2 English level

Skills & Competencies

  • Organization skills, multitasking.
  • Quality minded, autonomous, rigorous, attentive to details, persevering and pro-active.
  • Teamwork
  • Good communication skills and cheerful.
  • Computer skills: Microsoft Office, Ms Teams

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

  • Delivers Results
  • Leads with Integrity and Respect
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

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