Senior QA Associate Release Car-t Europe - Gent, België - Johnson & Johnson

Johnson & Johnson

Geverifieerd bedrijf

Gent, België

2 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Johnson & Johnson (J&J) is recruiting a Sr QA Associate for the CAR-T hub in Europe. 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, J&J has build two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing J&J Beerse site. CAR-T investigational medicinal and commercial CAR-T products are manufactured in the Ghent facilities.

In this role, you are reporting in the QA/QP organization and work closely with your peers from Quality Assurances Operations and Quality Control.

The Sr QA Associate, CAR-T Europe is responsible that product and process related investigations, complaints, batch records reviews are properly handled on time and in line with all ATMP/GMP requirements.

Major Responsibilities:

Support indepth investigations by providing technical, quality and compliance expertise
Ensure that deviations/complaints are timely and properly investigated. Deviations/complaints with potential impact on patients and/or product supply are properly escalated
Ensure that adequate CAPA's are defined for investigations with potential quality impact
Support the preparation, execution and followup of inspections and audits
Participate to the quality oversight programs of the operational activities by documented QA approval of GMP documentation and support in the different quality review meetings
Establish and maintain effective working relationships with the different business partner and Legend Biotech to ensure alignment of objectives and deliverables
Ensure and manage the implementation and execution of the different quality system processes
Support the operational and QA departments by providing coaching and/or training
Review of batch documentation and review analytical results

Qualifications:

Experience and Skills:

Certified Industrial Pharmacist with at Least 3 years cross functional experience in pharmaceutical industry.
Indepth understanding of pharmaceutical product development, qualification, packaging, validation, testing, release and distribution processes.
Uptodate knowledge and indepth understanding of relevant pharmaceutical legislation related to clinical trials and cGMP regulations related to manufacturing of cell therapy products as well as knowledge of Good Tissue Practices.
Strong analytical thinking and decisionmaking skills.
Excellent verbal and written communication skills to negotiate and communicate with external and internal customer and partners.
Experience working with Quality systems is required.
Experience with aseptic processing and technics is required.
Highly organized and capable of working in a team environment with a positive attitude under some supervision.
Good written and verbal communication skills are required.

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