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Deviation / CAPA Expert (M/F)

June 9th 2020

MaSTherCell is a dynamic and global Contract Development and Manufacturing Organization (CDMO) on a mission to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies to the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, MaSTherCell’s teams are fully committed to helping their clients fulfil their objective of providing sustainable and affordable therapies to their patients.

Mission Description

RESPONSIBILITIES :         

  • Responsible for the effectiveness of the Deviation and CAPA processes (lean and efficient) in production department
  • Responsible for the progressive reduction of recurrent deviations through adequate root cause analysis and implementation of effective CAPAs in production department
  • Provide overall deviation and CAPA content assessment through application of adequate methodologies/tools (DMAIC methodology,5 whys, fishbone,...) for production department.
  • Ensure adequate Key Performance Indicators and processes ( i.e. tier meeting, deviation 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 (for production deparment)
  • Escalade risks, problems, proposing action plans to the Management for decisions regarding deviations & CAPA for production department
  • Analyse, lead and coordinate coaching or mentoring based on individuals' needs.
  • Evaluate applicability of best practices (deviations & CAPA) within the production department and provide pro-active feedback for their implementation and use
  • Be the local operational representative expert of the deviation and CAPA process for production department and act as a coach for "deviation fronter" during inspections/ client audits/visits.
  • Actively contribute to driving cultural change in 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

OBLIGATORY REQUIREMENTS

  • 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 similar position.
  • Good understanding of regulatory guidance and cGMP/GQP/GQMP.

USEFUL REQUIREMENTS

  • Fluency in French.
  • Good reading, speaking and writing skills in English.
  • Quality minded, rigorous, customer oriented and continuous improvement driven.
  • Facts and data solution-oriented.
  • Demonstrated cross functional team spirit.
  • Organization skills, multitasking, flexibility and autonomous.
  • Good communicator, very good interpersonal capabilities, to be able to act as a coach.

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 : MaSTherCell