Join our Talent Pool – Computerized System validation (CSV) professionals
Quality Assistance — Thuin, Belgique
Ready to make a difference? As part of our continued growth and to anticipate future recruitment needs, we are building a talent pool of Computerized System Validation (CSV) professionals. By joining this talent community, you will be among the first candidates to consider when new opportunities matching your expertise become available. As a Computerized System Validation (CSV) Specialist, you will help ensure that the computerized systems used within our laboratories are reliable, compliant and fit for their intended purpose. These systems play an integral role in generating data that drive drug development, quality control and the release of medicines to patients. You will join a team of 4 professionals dedicated to CSV and report directly to the Team Leader. Working closely with Laboratory, Quality and IT teams, you will help maintain the validated state of computerized systems throughout their lifecycle, ensuring data integrity and regulatory compliance across critical laboratory activities. Your key responsibilities Here’s what you’ll take ownership of: Define validation strategies for laboratory equipment computerized systems Prepare, review and execute CSV documentation, including URS, DQ, IQ, OQ, validation reports and archiving records Monitor suppliers during the installation of computerized systems Ensure compliance with internal procedures throughout the system lifecycle Contribute to internal audits through validation expertise and documentation support Collaborate with IT, Quality Assurance and Operations teams to maintain project compliance Assess system changes and determine their impact on validation status Support users during system onboarding and troubleshooting activities Skills you'll need to bring To succeed in this role, you’ll bring: Expertise in Computerized System Validation (CSV) Knowledge of laboratory computerized systems and their lifecycle management Understanding of validation documentation, including URS, DQ, IQ, OQ and validation reports Familiarity with industry best practices and regulatory requirements, including FDA 21 CFR Part 11, EU GMP Annex 11 and GAMP 5 (Good Automated Manufacturing Practice) Knowledge of data integrity principles within GxP environments Experience with change control and validation impact assessments Understanding of audit and inspection requirements in regulated environments Attention to detail when reviewing compliance and validation documentation Ability to collaborate effectively with Quality Assurance, IT and Operations teams Analytical mindset for troubleshooting and problem solving User-focused approach to onboarding and system support Our commitment to you From day one, you'll have access to a structured onboarding programme and continuous learning opportunities designed to strengthen your technical expertise in analytical sciences. You'll also benefit from: Significant investment in technologies that keeps your laboratory tools at the forefront of the industry A collaborative scientific culture where knowledge sharing is encouraged A working environment that supports wellbeing, flexibility and career growth The satisfaction of contributing to medicines that can make a meaningful difference to patients worldwide Who we are (and why it matters) At Quality Assistance, analytical science supports one clear objective: helping innovative treatments reach patients faster. From our site in Thuin, we work alongside pharmaceutical companies, providing analytical data that meets the expectations of international regulatory authorities, including the EMA and FDA. Supported by a team of nearly 280 experts and continuous investment in advanced technologies, we help our partners move their projects forward through reliable, high-quality data. Every analysis contributes to maintaining the safety, quality and integrity required throughout the drug development process. Joining us means becoming part of a collaborative environment where scientific expertise is valued, professional growth is encouraged, and every contribution helps advance public health.
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