Weesp, NLD
1 day ago
CSV Specialist
**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! **Abbott Established Pharmaceuticals** 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. **About the role** 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. **What You’ll Do** + 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. **What We’re Looking For** + 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. **Why Join Us?** + 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. **Ready to make a difference?** Apply now and help us shape the future of compliance! All applications needs to include a CV and cover letter. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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