描述
The QA Associate Release CAR-T Europe is responsible for the release of CAR-T investigational medicinal and commercial CAR-T products manufactured in the Ghent facilities.
Key Responsibilities:
- Taking responsibility as Release Responsible of both investigational medicinal and commercial CAR-T products manufactured at the Janssen/Legend Biotech facilities in Ghent.
- Act as an expert resource in assessing and maintaining quality and compliance levels
- Continuously challenging the status quo and lead the development and implementation of breakthrough initiatives that deliver sustainable improvement in organizational and quality performance
- Establish and maintain effective working relationships with the different business partner and Legend Biotech to ensure alignment of objectives and deliverables
- Ensure quality oversight of the operational activities by documented QA approval of GMP documentation and support in the different quality review meetings
- 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
- 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 CAPAs are defined for investigations with potential quality impact
- Support the preparation, execution and follow-up of inspections and audits
资格
- A minimum of a Master Degree in Engineering, (Pharmaceutical) Science or equivalent technical discipline is required.
- QP certification is a plus.
Required:
- 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.
- Highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Good written and verbal communication skills.
- English: fluent.
Preferred:
- Experience with aseptic processing and technics