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Production Deviation and Change 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 main responsibilities of the role are:

  • Responsible for the effectiveness of the Deviation, CAPA, and Change processes (lean and efficient) in the production department
  • Responsible for the progressive reduction of recurrent deviations through adequate root cause analysis and implementation of effective CAPAs in the production department
  • Provide overall deviation and CAPA content assessment through application of adequate methodologies/tools (DMAIC methodology,5 whys, fishbone,...) for the production department.
  • Ensure adequate Key Performance Indicators and processes ( i.e. tier meeting, deviation, CAPA and change review board, …) are in place and in use to monitor, track, and drive progress with respect to i.e. human errors, recurrent deviations, deviation overdue, CAPA overdue, CAPA efficiency and CAPA effectiveness checks, change overdue (for production department)
  • Escalade risks, problems, proposing action plans to the Management for decisions regarding deviations & CAPA & changes for the production department
  • Analyze, lead and coordinate coaching or mentoring based on individuals' needs.
  • Evaluate the applicability of best practices (deviations & CAPA & change) within the production department and provide pro-active feedback for their implementation and use
  • Be the local operational representative expert of the deviation, CAPA, and change processes for the production department and act as a coach for deviation during inspections/ client audits/visits.
  • Actively contribute to driving a cultural change in the production department, building up of capabilities and continuous improvement within the department
  • Actively benchmark local practices (not included in Best Practices package) with other departments.

Candidate profile

  • Minimum University degree in biology, pharmacy, clinical chemistry, bioengineering, or relevant experience in a similar position in the sector of Biotech/Pharma/Cell therapy
  • At least 5 years of experience in GMP environment and aseptic production, in a similar position.
  • Fluency in French, Professional proficiency in English.
  • Good communicator, very good interpersonal capabilities, to be able to act as a coach
  • Flexibility, very good organization skills, multitasking, proactive and autonomous.
  • Facts and data solution-oriented, quality-minded, rigorous, customer-oriented, and continuous improvement driven.
  • Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

 

Offer

  • Full-time position (40h/week).
  • The opportunity to take part in a growing dynamic biotech company.
  • A human-sized working environment 

Contact Details

To apply for this job, please send your application on the following link : Catalent