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Quality Assurance Specialist for Gene Therapy
il y a 2 semaines
We are seeking a highly skilled Quality Assurance Specialist to join our team in Braine-l'Alleud. As a Gene Therapy Quality Partner, you will play a crucial role in the Genesis project GMP Readiness program. Your primary responsibility will be to ensure timely health authorities authorization to manufacture Gene Therapy clinical batches in the new facility pilot plant.
Key Responsibilities:
- Develop and implement quality operational procedures for the new Gene Therapy facility, integrating them into existing QMS systems.
- Collaborate with the project team to assess the GMP & Operations Readiness program's progress against key milestones.
- Manage materials and product specifications, executing incoming materials release and supporting supplier qualification programs.
- Drive the development of a Contamination Control Strategy and establish an inspection readiness program.
- Prepare the new Gene Therapy Facility Site Master File.
Requirements:
- A scientific master's degree or equivalent is required. Minimum 5-8 years of QA oversight experience in a GMP manufacturing environment is essential. Experience with new manufacturing facilities seeking Health Authorities certification is also necessary. Good knowledge of Biopharmaceuticals or Gene Therapy manufacturing is a must. Fluency in English and French is required. QP Registration in Belgium is an asset. Strong understanding of GMP, CFR, Eudralex for Biopharmaceutical manufacturing is essential.
