Materials Quality Expert

2 weken geleden


Leiden, Zuid-Holland, Nederland Galapagos Voltijd

We are Galapagos, a dynamic growing Biotech company.

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 Materials Quality 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.

Your key responsibilities will include:

  • Drafting a comprehensive risk assessment for QC and MFG materials, considering guidelines and regulations relevant to the quality of materials used in manufacturing and quality control settings.
  • Defining Full vs Reduced testing requirements for materials based on Phase III/Commercial needs, ensuring compliance with industry standards and regulations.
  • Coordinating the qualification process for materials, ensuring appropriate testing, documentation, and compliance with relevant guidelines.
  • Identifying and evaluating suitable contract testing labs for specific testing activities, considering quality, reliability, and cost-effectiveness.
  • Collaborating with the development team to establish in-house analytical development processes, methodologies, and equipment necessary for quality control.
  • Assisting QC management in the implementation of a revised incoming goods strategy, ensuring seamless integration of new processes and practices.
  • Staying updated with industry trends, regulations, and best practices related to materials quality in manufacturing and quality control settings.


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