About This Vacancy About The Role We are looking for a Quality Specialist – Extractables & Leachables (E&L) to support the Sterile Filtration team at our manufacturing site in Boxmeer. In this role, you will be responsible for executing Extractables & Leachables risk assessments and providing scientific and quality expertise to ensure compliance with regulatory and GMP requirements. In addition, you may occasionally support projects within the Global Packaging Center of Excellence, giving you exposure to international stakeholders and broader quality initiatives.
Key Responsibilities
Execute Extractables & Leachables (E&L) risk assessments for manufacturing processes and materials.
Evaluate potential quality and compliance risks within a GMP-regulated environment.
Prepare, review, and maintain technical GMP documentation, including SOPs, protocols, deviations, CAPAs, and quality assessments.
Collaborate with cross-functional teams to investigate and resolve complex quality-related challenges.
Support continuous improvement initiatives to enhance quality systems and processes.
Ensure timely completion of assignments while maintaining high standards of accuracy and compliance.
Act as a quality subject matter expert for E&L-related topics.
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