Quality Specialist Extractables & Leachables

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.

What we expect from you

Your Profile

• Bachelor’s, Master’s, or PhD degree in Biology, Chemistry, Pharmacy, or a related scientific discipline.
• Proven experience within the pharmaceutical industry and a strong understanding of GMP requirements.
• Experience authoring and reviewing technical documentation such as SOPs, protocols, deviations, CAPAs, and risk assessments.
• Hands-on experience performing Extractables & Leachables assessments.
• Strong analytical and problem-solving skills with the ability to manage complex projects effectively.
• Ability to work independently as well as within multidisciplinary teams.
• Professional proficiency in English, both written and spoken.
• Excellent organizational skills with the ability to manage multiple priorities and meet deadlines.
• Strong attention to detail and commitment to quality.
• Effective interpersonal skills and the ability to build relationships across departments and functions.
• A continuous improvement mindset and a genuine willingness to learn and develop.
• Residing within a reasonable commuting distance of Boxmeer.

What you can expect from us

Why Join This Opportunity?

• Work in a highly specialized role within a leading pharmaceutical manufacturing environment.
• Contribute directly to product quality, compliance, and patient safety.
• Collaborate with experienced professionals in both local and global teams.
• Gain exposure to international projects and cross-functional stakeholders.
• Enjoy a position that offers autonomy, responsibility, and opportunities for continuous development.

Are you ready to apply your expertise in Extractables & Leachables and make a real impact in a GMP-regulated environment? We would love to hear from you.