GMP Manufacturing Facility Lead

il y a 7 jours


Brainel'Alleud, Wallonie, Belgique Jefferson Wells Belgium Temps plein
About the Opportunity

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and access to trainings in technical matters and soft skills.

Your Responsibilities
  1. Implement new quality operational procedures into existing QMS systems.
  2. Assess GMP & Operations Readiness program progress against project key milestones.
  3. Manage materials and product specifications, execute incoming materials release.
  4. Contribute to the development of the Contamination Control Strategy.
  5. Qualify suppliers.
  6. Develop an inspection readiness program.
  7. Create the new Gene Therapy Facility Site Master File.
Your Profile
  • A scientific master's degree or equivalent.
  • At least 5-8 years of experience in QA oversight in a GMP manufacturing environment.
  • Experience with new manufacturing facilities seeking Health Authorities certification.
  • Strong knowledge of Biopharmaceuticals or Gene Therapy manufacturing.
  • Experience in health authorities' inspections.
  • Familiarity with 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.


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