Sr. QA Associate Car-t Emea
il y a 2 semaines
Johnson & Johnson (J&J) is recruiting a Senior 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 Senior 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 in-depth 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 follow-up 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**:
- Certified Industrial Pharmacist with at Least 3 years cross functional experience in pharmaceutical industry.
- In-depth understanding of pharmaceutical product development, qualification, packaging, validation, testing, release and distribution processes.
- Up-to-date knowledge and in-depth 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 decision-making 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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