Key Skills

Job Description

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.

Core Responsibilities

Execute Extractables and Leachables risk assessments for manufacturing processes and materials, and provide scientific and quality expertise to support regulatory and GMP compliance. Maintain technical GMP documentation, help investigate and resolve quality challenges, and contribute to continuous improvement and related projects.

Requirements

The role calls for expertise in Extractables and Leachables risk assessment and the ability to evaluate quality and compliance risks in a GMP-regulated environment. It also requires preparing and maintaining technical documentation, collaborating across teams, and completing work accurately and on time.