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QC Equipment validation 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 equipment validation expert main role is to implement and maintain the QC infrastructure & equipment in the Quality Control department. He/She reports to the QC supervisor QC services. In order to fulfill his/her role, he/she:

  • Is involved in the QC equipment management in partnership with technical service and quality control operations (order, installation, maintenance, qualification..)
  • Drafts/reviews QC documents linked to equipment qualification (URS, IQ/OQ/PQ, instructions, Change control,…)
  • Acts as an interface with subcontractors in partnership with technical service
  • Is involved in the installation, modifications and improvements of QC lab infrastructures
  • Is involved in EMS management 
  • Takes the lead on deviations/CAPA regarding QC equipment, EMS and infrastructure
  • Takes part to internal and/or external audits, if necessary
  • Maintains an open and effective communication with all other QC team members and with other departments (Production, QA, and Technical Service).
  • Functionally manages QC supports

In addition to these activities, the current challenges of the position are:

  • Support the QC supervisor in the construction of the commercial facility (QC labs implementation, equipment qualification,…)
  • Support the QC supervisor in the implementation of 21 CRF part 11 compliant softwares on equipment.

Candidate profile

Qualifications & Experience

  • At least Graduate level in chemistry, biochemistry, clinical chemistry, biology, etc.
  • At least 2 year’s experiences in cGMP environment.
  • experience in equipment validation
  • At least B1 English level - fluent in French

Skills & Competencies

  • Organization skills, multitasking.
  • Quality minded, autonomous, rigorous, attentive to details, persevering and pro-active.
  • Teamwork and teaching skills.
  • 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