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Materials Quality Consultant
4 weken geleden
Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines, we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happener’.
For our Cell Therapy organization in Leiden/NL, we are looking for a Materials Quality Consultant (contractor) for 6 months.
Scope of the job
We are seeking a highly skilled and experienced Materials Quality Consultant to support our organization in transitioning from an Incoming Goods process suitable for Phase I/II Clinical to a process suitable for Phase III/Commercial. The consultant will play a crucial role in drafting a risk assessment for QC and MFG materials, defining Full vs Reduced testing requirements, coordinating Material Qualifications, identifying suitable contract testing labs, coordinating with the development team for in-house analytical development, and supporting QC management in implementing a revised incoming goods strategy.
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