- Act as an expert resource supporting the processes of the QA/QP Operational team.
- Finetune requirements to ensure fit-for-purpose processes contributing to QA release.
- Support in-depth investigations and complaints by providing quality and compliance expertise.
- Ensure that issues with potential impact on patients and/or product supply are properly escalated.
- Ensure that adequate CAPA's are defined for issues with potential quality impact.
- Support inspection and audit readiness programmes.
- Support the preparation, execution and follow-up of inspections and audits.
- Train/Coach colleagues
- Participate to the quality oversight programs of the operational activities by documented QA approval of GMP documentation.
- Perform QA review of GMP documentation, e.g. risk management, APR, CPV,..
- Provide support in the different quality review meetings and quality improvement initiatives.
- Drive continuous improvement.
- Establish and maintain effective working relationships with the different business partners and Legend Biotech to ensure alignment of objectives and deliverables.
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QA/QP Support Lead, CAR-T Europe - Ghent, België - Johnson & Johnson
Beschrijving
Johnson & Johnson (J&J) is recruiting a QA/QP Support Lead 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 blood cancer treatment that uses the strength of the patient's own immune system.
We are therefore working passionately on expanding our capacity for CAR-T treatments in Europe, both at our existing site in Beerse (QC laboratories) and in Ghent, where we have built two CAR-T manufacturing centers in the Ghent area (Belgium).
We are looking for strong talents who are eager to participate in this innovative and hopeful venture.
The QA/QP Support Lead is part of the QA/QP Operational team and is responsible to ensure QA operational support and enhancements to the QA processes in line with all ATMP/GMP requirements.
Key Responsibilities:
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