QA Specialist — GxP, ISO Compliance & Improvement

Eurofins; Oegstgeest; On-site; EUR 60,000 - 85,000; Full time

Benefits offered by this job

25 days vacation

Travel allowance

Pension scheme

Training & development

Good Habitz access

Job summary

Eurofins BioPharma Product Testing Leiden B.V. is seeking a Quality Assurance Specialist to ensure GMP-compliant operations across Chemistry, Biosafety, and Manufacturing. You will review deviations, CAPAs, and change controls, while maintaining data integrity and supporting audits.

You will collaborate with cross-functional teams and mentor colleagues to strengthen our quality culture in a dynamic laboratory setting at Leiden Bio Science Park.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences or a related discipline.
• Experience in a GMP-regulated environment in pharma/biopharma.
• Strong knowledge of GxP regulations, quality systems, and data integrity.
• Experience with deviations, CAPAs, change controls, risk assessments, and audits.
• Fluent English; Dutch is an advantage.

Responsibilities

• Ensure compliance with GxP, ISO and internal quality standards.
• Act as QA SME for Chemistry Testing, Biosafety Testing, and/or Manufacturing Operations.
• Review, approve, and close deviations, change controls, customer complaints, OOS investigations, and CAPAs per GMP requirements.
• Ensure high standards of documentation and data integrity.
• Support QA activities and continuous improvement initiatives.
• Contribute to risk management through risk assessments and root cause investigations.
• Train, coach, and mentor colleagues while fostering a strong quality culture.
• Support digitalization and automation initiatives within Quality Assurance.
• Collaborate across departments to ensure compliance and customer satisfaction.

Skills

Analytical skills

Problem-solving

Decision-making

Communication skills

Stakeholder influence

Continuous improvement

Proactive attitude

Education

Bachelor’s or Master’s in Life Sciences/related

Tools

Quality management systems

Job description

Eurofins BioPharma Product Testing Leiden B.V. is seeking a Quality Assurance Specialist to ensure GMP-compliant operations across Chemistry, Biosafety, and Manufacturing. You will review deviations, CAPAs, and change controls, while maintaining data integrity and supporting audits.

You will collaborate with cross-functional teams and mentor colleagues to strengthen our quality culture in a dynamic laboratory setting at Leiden Bio Science Park.