CSV Specialist

Are you passionate about Computer System Validation (CSV) and ensuring data integrity in a regulated environment? Do you thrive on influencing strategy, coaching teams, and driving compliance excellence? If so, we want you on our team!

We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

As a CSV Specialist, you will play a critical role in safeguarding GMP-related computer systems. You’ll act as a trusted advisor and subject matter expert, guiding policy decisions, leading validation projects within the quality control department, and supporting audits with confidence.

• Advise & Influence: Shape policy proposals and implementation strategies for CSV and data integrity in GMP environments.
• Validate & Maintain: Ensure the validated state if laboratory software by managing change control and updating documentation in compliance with GxP and cybersecurity requirements.
• Drive Compliance: Prepare and execute validation plans, protocols, and reports for computer systems.
• Lead Audits: Represent CSV expertise during audits and project reviews.
• Continuous Improvement: Conduct periodic system reviews and recommend re-validation when needed.

• Bachelor’s degree in STEM.
• 2-3 years of relevant experience in Computer System Validation.
• 2-3 years of experience in a laboratory environment is strongly preferred.
• Strong knowledge of GAMP5 and regulatory guidelines (EU GMP Volume 4, Annex 210, 211, 11).
• Analytical mindset with strategic influence and stakeholder management skills.
• A proactive team player who drives results and anticipates challenges.
• Fluent in Dutch and English, verbally and written.

• Be part of a mission-driven organization committed to quality and compliance.
• Work in a collaborative environment where your expertise makes an impact.
• Opportunities for professional growth and continuous learning.

Apply now and help us shape the future of compliance! All applications needs to include a CV and cover letter.