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Qs Document Management Associate Car-t

Il y a 3 mois

Beerse, Flandre, Belgique Johnson & Johnson Temps plein

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Systems (QS) Document Management Associate CAR-T.

The position will be based in Ghent Belgium.

CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient's own immune system.

They are created from the patients' own T cells and are engineered to eliminate cancer cells expressing a specific antigen.

To support the CAR-T program in EMEA, Janssen is building two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing Janssen Beerse site.

The QS Document Management Associate CAR-T is responsible for quality systems document management support of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.


Major Responsibilities

  • Provide administrative support in the lifecycle of document management:
  • Management of procedures and related documents in Truvault
  • Management of training setup in Summit
  • Fulfill the site key user responsibilities, represent CAR-T Belgium in global forums/team meetings, mentor site users for document management process, and control access to the system
  • Build and maintain a clear archive in line with the Worldwide Record Information Management policies
  • Run reports and conduct data analysis to support monitoring of key performance indicators (e.g. periodic review)
  • Perform tasks consistent with the JnJ policies, quality systems and cGMP requirements.
  • Ensure and maintain a state of inspection readiness
  • Identify improvements and drive for implementation

Qualifications:

  • Experience working with Quality Systems document management systems
  • Strong knowledge of Microsoft Office tools, preferred knowledge of Truvault/Summit
  • Good written and verbal communication skills in both Dutch and English
  • You have a quality mindset, keeping customer requirements in mind
  • You are flexible to support shifting priorities
  • You are a team player that gets energized by collaborating with colleagues and providing support to the site users
  • You continouosly look for improvements