JOBS

Back

QC EXPERT INFRA & EQUIPMENT (M/F)

October 2nd 2020

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. To lead its increasing number of recruitments, Catalent Cell and Gene Therapy is looking for a highly motivated QC Expert Infra & Equipment.

Mission Description

The QC Expert - infra & equipment main role is to implement and maintain the QC infrastructure & equipment in the Quality Control department. He reports to the QC supervisor infra & equipment.
 
In order to fulfill his role, he:
  • 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

The QC Expert - infra & equipment main role is to implement and maintain the QC infrastructure & equipment in the Quality Control department. He reports to the QC supervisor infra & equipment.
In order to fulfill his role, he:
  • 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.
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 contrac.
  • 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 : https://bit.ly/2SecsO5