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QC training 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 training specialist main role is to deliver theoretical and practical training courses related to Quality Control activities. He/She reports to the QC training coordinator within the QC services. In order to fulfill his/her role, he/she:

  • Train the QC operators to the generic activities/GMP training courses related to QC processes
  • Train production and QC operators to visual inspection test
  • Train punctually QC operators to analytical specific steps
  • Initiate and/or improve and/or review specific training supports/materials
  • Administrative management of training documents: preparation and completion of forms, follow-up and encoding
  • Write working instruction
  • Check that training’s contents are well applied on the field
  • Participate in the improvement and/or replacement of the current system
  • maintain QC Training KPI in green
  • Takes the reviews deviations/CAPA, Change Control, Risk Analysis quality system documents related to the training system;
  • Maintains an open and effective communication with all other QC team members and with other departments

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

  • Rearrangement of training system from a projects organisation to a platform organisation with dedicated analytical methods.
  • Decrease the time needed to make the operators operationals
  • In addition, the candidate will participate in the general improvement of the quality system linked to training as part of the commercial readiness program.

Candidate profile

Qualifications & Experience

  • At least Bachelor level in chemistry, biochemistry, clinical chemistry, biology, etc.
  • At least 3 years’ experience in cGMP or experience in a similar position
  • English level: at least A2
  • Computer skills:  Microsoft office, ComplianceWire, Documentum, TrackWise are a plus.

Skills & Competencies

  • Organization skills, multitasking;
  • Quality minded, autonomous, rigorous, attentive to details, persevering and pro-active;
  • Teamwork and very good teaching skills;
  • Good communication skills and cheerful;

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