Qs Document Management Associate Car-t - Gent, België - Johnson & Johnson

Johnson & Johnson

Geverifieerd bedrijf

Gent, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

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