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