Quality Specialist Extractables & Leachables

TMC Sweden; Boxmeer; On-site; EUR 60,000 - 85,000; Full time

Job summary

TMC Sweden is seeking a Quality Specialist – Extractables & Leachables (E&L) to support the Sterile Filtration team at our Boxmeer manufacturing site. You will execute E&L risk assessments and provide scientific and quality expertise to ensure compliance with regulatory and GMP requirements.

You may also support projects within the Global Packaging Center of Excellence, gaining exposure to international stakeholders and broader quality initiatives.

Qualifications

• Execute Extractables & Leachables (E&L) risk assessments and ensure compliance with regulatory and GMP requirements.
• Prepare, review and maintain technical GMP documentation (SOPs, protocols, deviations, CAPAs, quality assessments).
• Act as quality subject matter expert for E&L topics and support cross-functional teams.

Responsibilities

• Execute E&L risk assessments for manufacturing processes and materials.
• Evaluate potential quality and compliance risks in GMP-regulated environment.
• Prepare, review, and maintain GMP documentation (SOPs, protocols, deviations, CAPAs).
• Collaborate with cross-functional teams to investigate and resolve quality challenges.
• Support continuous improvement of quality systems and processes.
• Ensure timely completion of assignments with high accuracy and compliance.
• Act as quality SME for E&L topics.

Skills

Quality Assurance

GMP Compliance

Risk Assessment

Regulatory Knowledge

Cross-functional Collaboration

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.