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EMS Sampler

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Sophie Steels
Senior Recruiter



Sophie Steels
Senior Recruiter
+32 496 49 18 21


Description de l'emploi

Our client is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. They are developing advanced cell therapies

The EMS SAMPLER is a position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.

  • Serves as a Quality person in plant in support of cell therapy manufacturing.
  • Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
  • Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.
  • Review and approve manufacturing procedures and batch records
  • Real time review of all documentation and reporting in support of process unit operations and release activities.
  • Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
  • Strive to reduce non-conformances in supported areas by proactively driving compliance.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • Support regulatory inspections and audits by ensuring inspection readiness within facility.
  • Perform internal housekeeping audits.


Profil

Do you have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy?

  • Aseptic processing in ISO 5 clean room and biosafety cabinets.
  • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
  • Great attention to detail and ability to follow the procedures.
  • The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
  • Good written and verbal communication skills are required.
  • Ability to summarize and present results, and experience with team-based collaborations is a must.
  • Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
  • Must exhibit strong leadership skills and effectively develop others.
  • Ability to collaborate well with stakeholders, customers and peers.
  • Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
  • Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
  • Ability to manage conflict and issues that arise with internal or external customers.
  • Fluency in Dutch and English


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Coordonnées de contact

Formation et expérience

Nombre d'années d'expérience*
+32 496 49 18 21