QA Car-t Qualification Lead Emea
il y a 1 mois
Johnson & Johnson Innovative Medicine is recruiting a CAR-T QA C&Q Lead Engineer for the CAR-T hub in Europe.
**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 IM is starting up two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing Janssen Beerse site.
The CAR-T QA C&Q Lead Engineer is part of the CAR-T QA Qualification Team in Ghent. He/She will be responsible for review and approval of qualification and requalification activities, related to Facilities and Utilities (F&U) and Process Equipment at the Janssen/Legend Biotech facilities in Ghent.
**Responsibilities**:
- Responsible for managing a team of CAR-T QA Qualification Engineers and providing QA oversight for qualification activities.
- Will work closely together with the MAM (make asset management) and E&PS department and guard the qualification status of critical production assets by ensuring that all system critical aspects related to facilities & utilities, product and process requirements are identified; qualified and controlled by a mitigation plan and ensure that deviations related to equipment issues with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented
- Will work closely together with the manufacturing department to approve new change controls and to ensure that deviations with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented
- Will build a strong connect with different quality organizations (e.g. external quality)
- Will manage the compliance status of critical production (make) assets by means of review and approval of procedures e.g. calibration rationales, calibration master forms and completed calibration records, master data set-up, maintenance plans and follow up daily operations activities by review and approval of data integrity deliverables such as system audit trail and user access reviews
- Participates in the preparation for regulatory and customer inspections and act as a spokesperson for QA qualification
- Approves qualification documents (change controls, master documents, protocols, reports, rationales, SOP’s, URS, IA, QSR, etc.) including discrepancies/events/non-conforming situations and related corrective actions (correction, CPA) occurring during execution of qualification activities.
- Participates in system and process improvement / optimization projects and assure quality and compliance aspects and maintain a current knowledge of international regulations, guidelines and industry practices and become the QA process expert.
**Qualifications**:
- master’s degree in engineering with chemistry or analytical background or in pharmaceutical sciences
- awareness of quality; have knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell therapy products and you see it as a challenge to defend our strategy and documents towards health authority inspections.
- affinity with computerized systems, System parameter configurations and data management in critical production assets
- thorough knowledge of Dutch and English, both orally and in writing
- Strong analytical thinking, risk assessment and communication skills
- Collaboration and teaming skills
**What is in it for you?**
You will be part of an enthusiastic team that has a strong quality focus on technology, qualification, automation, and continuous improvement. Employees are very valuable to our organization and development is a daily responsibility. Through on the job training, e-learning, implementation of various projects and programs we ensure personal growth by focusing on your talents. We offer you a contract of indefinite duration with an attractive salary package including extra-legal benefits such as meal vouchers, additional pension plan and hospitalization insurance.
**Application Process**
**Equal Opportunity Statement**
The employers of the Johnson & Johnson family value diversity and inclusion. We are committed to building diverse teams that reflect both the patients and the partners we support. We strive to create an inclusive work environment where our people feel at home and are given the space to realize their full potential.
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