Contracting – Brabant Wallon 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 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 Jefferson Wells offers you a permanent contra... Writing, Biopharmaceuticals, Gene Therapy, VOS, GMP, Support Management, Registration, Customer Needs, Health System, Biopharmaceuticals, Manufacturing, Operations, Asset, Consolidation, Change Control, Quality assurance, Projects, Inspection, Science, Manufacturing, Training, Implementation Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!
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