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Raw material release expert (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 expert 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
  • Manage and follow the MQP RM workbook, tools for timeline, due date.
  • Update the RM Material risk analysis list compiled
  • Contact suppliers
  • Draft or update raw materials specifications.
  • Draft or update Incoming Product Sampling and QC.
  • Contact subcontractor’s laboratory for raw materials testing. (quotation request, challenge analytical proposal,… )
  • Be the point of contact for specific project MPQ;
  • Be the Subject matter expert and provide answer when required
  • Participate to client meeting and explain the proposed material plan
  • Expertise or strong knowledge in pharmaceutical regulatory requirements, Eudralex, ICH, IMPD, …
  • Challenge the requirements for Catalent projet in based on the procedure, directives, and regulatory requirements.
  • Follow and update the versions of the EP/USP pharmacopoeia monographs when the release date is schedule.
  • Initiate the CHC for new requirement on Raw material, follow the implementation in Catalent Gosselies
  • Update the Catelent documentation on based of CHC and new requirement.
  • Follow up Pharmacopeia regulatory requirements and the others quality system: ISO, …
  • Perform his/her duties and document his/her work according to Catalent’s current procedures and GMP rules
  • Initiate, review, follow the deviations, OOS, CHC and lead necessary investigation. Implement CAPA.

Raw Material Testing

  • Write and review analytical protocol for RM testing
  • Follow Raw material QC testing in due time according to the team planning, and in compliance with effective instructions /procedures and all laboratory/safety procedures
  • Double check filled forms or data generated by QC Experts / Specialists / Technicians, for testing which he / she is trained.
  • Follow-up and review of raw data from subcontractors’ raw materials testing to assess for the release of the outsourcing activities for RM/CP/SM.
  • Ensure the follow-up of Raw material reference standard data base
  • Qualification of the reference standard, initial and periodical qualification
  • Expiry date management
  • Support the Supervisor in the day to day management
  • Raw Material Release

Ensure the review and the release of RM:

  • Double check of raw data of the analytical testing (in house or from subcontractors).
  • Double Check supplier documentations
  • Perform the release for the RM on ERP
  • back-up or support the RM Service activities.
  • Support the RM team in the release process. Be a referent for the potential question.
  • Help the team to achieve its work and fluidify/improve the processes where applicable
  • Participate actively to the weekly QC team meeting
  • Maintain effective, constructive and positive communication with all QC team members, other departments and suppliers.
  • Works to keep KPI in green.
  • Takes part to internal and/or external audits, if necessary
  • Maintain effective, constructive and positive communication with all QC team members, other departments and suppliers.

Candidate profile

  • Master degree or higher in biology, biomedical sciences, biochemistry, clinical chemistry or relevant experience in a similar position in the sector of biotechnology/pharma/cell therapy
  • Experience in cell therapy or quality control of cells from human tissue origin is an real asset
  • At least 5 years of experience in cGMP environment, Regulatory affairs and/or quality control/quality assurance
  • Min 2 years in material qualification/testing
  • At least B1 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

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