Contracting – Brabant Wallon
Gene Therapy Quality Partner
Functieomschrijving
As a Gene Therapy Quality Partner, you will support the Genesis project GMP Readiness program to timely obtain health authorities authorization to manufacture Gene Therapy clinical batches in the new facility pilot plant.
- Drive the implementation of the new Gene Therapy facility quality operational procedures into existing QMS (change control, deviation management, release procedures, training, etc).
- Support the documented assessment of the GMP & Operations Readiness program progresses according to project key milestones.
- Support management of materials & product specifications, execute incoming materials release
- Support the consolidation and writing of the Contamination Control Strategy
- Drive the supplier’s qualification program
- Establish and drive the inspection readiness program
- Drive the preparation of the new Gene Therapy Facility Site Master File
Profiel
- Scientific master’s degree or equivalent
- At least 5 to 8 years of experience of QA oversight in a GMP manufacturing environment
- Experience of a new manufacturing facility seeking Health Authorities certification
- Good knowledge of Biopharmaceuticals or Gene Therapy manufacturing
- Experience in health authorities’ inspections
- Strong Knowledge of GMP, CFR, Eudralex for Biopharmaceutical manufacturing
- Fluency in English and French
- QP Registration in Belgium is an asset
- Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
- Strong understanding of a risk-based approach
- Able to understand customers’ needs and technical requirements
Aanbod
- Bedrijfswagen
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, Toon emailadres
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