Materials Quality Consultant

4 weken geleden

Leiden, Nederland Galapagos Voltijd

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.

Your role

Draft 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. Define Full vs Reduced testing requirements for materials based on Phase III/Commercial needs, ensuring compliance with industry standards and regulations. Coordinate the qualification process for materials, ensuring appropriate testing, documentation, and compliance with relevant guidelines. Identify and evaluate suitable contract testing labs for specific testing activities, considering quality, reliability, and cost-effectiveness. Collaborate with the development team to establish in-house analytical development processes, methodologies, and equipment necessary for quality control. Assist QC management in the implementation of a revised incoming goods strategy, ensuring seamless integration of new processes and practices. Stay updated with industry trends, regulations, and best practices related to materials quality in manufacturing and quality control settings.

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