Qc Technician Raw-material

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 modelling, 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.

To lead its increasing number of development and manufacturing projects, Catalent Cell and Gene Therapy is looking for a highly motivated QC Technician - Raw material Services.

The Role

The QC Technician - Raw material Services main role is to perform all administrative and laboratory activities inside the RM Services platform.

The responsibilities can be adapted and may cover the following topics: Raw Material Release, Sampling Management, outsourcing testing, Materiel qualification plan support,...)

Support the start of our commercial facility with a GMP quality grade and in an efficient way.

The RM Technician - RM Services reports to the QC Supervisor.

• Perform duties and document and work according to Catalent's current procedures and GMP rules.
• Perform QC tasks in due time according to the planning and in compliance with effective instructions and procedures.
• Request the picking of the incoming material reference samples and assure their storage in the appropriate conditions.
• Perform the QC sampling of the raw materials
• Participate to RM routine testing (visual inspection, ID testing).
• Prepare and follow the samples for analytical subcontracting. (outsourcing activity)
• Reference and retention QC samples management.
• Perform release of Raw Material
• Warn immediately the Supervisor or Manager in case of unusual event / result / OOS.
• Double checks filled forms or data generated from analytical subcontracting activities.
• Initiate or review DEV, OOS, CHC linked to RM Services platforms and lead necessary investigation. Implement CAPA.
• Draft Purchage order for analytical subcontracting testing.
• Draft QC documents
• Follow the needed training on due time.
• Maintain open, effective, constructive and positive communication with all other QC members and with other departments.
• Participate actively to the weekly QC meeting.
• Work to keep department KPI in green.
• Take part to internal and/or external audits, if necessary
• Bachelor's degree in biology, biomedical sciences, biochemistry, clinical chemistry, biochemistry or equivalent
• Experience in cell therapy or quality control of cells from human tissue origin is an asset.
• 2 years of experience in cGMP environment and/or quality control
• Experience in cGMP environment and/or quality control is a plus.
• Organization skills, multitasking, flexibility and autonomous.
• Teamwork
• Results oriented; problem solving.
• Quality minded, rigorous and proactive.
• Fluent in French
• English at least A2 level
• Computer skills: Microsoft Office, Compliance Wire, TrackWise are a plus.

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.

Position Benefits

• Fulltime position (40h/week).
• An indeterminate contract.
• The opportunity to take part in a growing dynamic Biotech company.
• A humansized working environment with a convivial atmosphere.

Catalent offre des opportunités enrichissantes pour faire avancer votre carrière Rejoignez le leader mondial du développement et de la production de médicaments et aidez-nous à proposer plus de 7 000 produits qui sauvent et améliorent la vie des patients du monde entier. Catalent est une société internationale passionnante et en pleine croissance où les employés travaillent directement avec des sociétés pharmaceutiques, biopharmaceutiques et de santé grand public de toutes tailles pour faire progresser de nouveaux médicaments, du développement précoce aux essais cliniques et à la mise sur le marché. Catalent produit plus de 70 milliards de doses par an, et chacune sera utilisée par quelqu'un qui compte sur nous. Rejoignez-nous pour faire la différence.

Catalent s'engage à protéger la santé et la sécurité de ses employés, de ses visiteurs et des clients et patients que nous servons.

À la suite de la pandémie mondiale, nous avons modifié bon nombre de nos processus de recrutement et d'intégration pour assurer la sécurité de tous.

Les équipes des ressources humaines communiqueront tous les processus et procédures de sécurité nécessaires à chaque étape.

Initiative personnelle. Rythme dynamique. Un travail significatif.

Visitez Catalent Careers pour explorer les opportunités de carrière.

Catalent est un

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