GMP Compliance Expert

il y a 6 jours


Brainel'Alleud, Wallonie, Belgique Jefferson Wells Belgium Temps plein

Responsibilities

  • Drive the implementation of 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.


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