Huidige banen gerelateerd aan Quality Assurance Specialist - Leiden, Zuid-Holland - Galapagos
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Quality Assurance Specialist
2 maanden geleden
About Galapagos
We are a dynamic and growing Biotech company with a strong presence in Europe and the US, headquartered in Mechelen, Belgium.
Our Mission
We are committed to changing lives by discovering and developing life-improving medicines. We pioneer for patients and strive to be at the forefront of innovation in the industry.
Job Overview
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.
Key Responsibilities
- 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.
Requirements
We are looking for a highly skilled and experienced Materials Quality Consultant with a strong background in quality assurance and regulatory compliance. The ideal candidate will have a deep understanding of industry standards and regulations, as well as excellent analytical and problem-solving skills.
