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Hainaut, Wallonia, Belgique
Quality Assistance Ltd.
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h3Ready to make a difference? Here's what awaits you. /h3pAs we continue to grow and prepare for future recruitment needs, we are building a btalent pool of Computerised System Validation (CSV) professionals /b. By joining our talent community, you will be among the first candidates to consider when new opportunities matching your expertise become available. /ppAs a bComputerised System Validation (CSV) Specialist /b, you will help ensure that the computerised systems used within our laboratories remain 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. /ppYou will join a team of bfour professionals /b dedicated to CSV and report directly to the bTeam Leader /b. Working closely with Laboratory, Quality and IT teams, you will help maintain the validated state of computerised systems throughout their lifecycle, ensuring data integrity and regulatory compliance across critical laboratory activities. /pulliDefine validation strategies for laboratory equipment computerised systems /liliManage CSV documentation, including its preparation, review and execution, covering URS, DQ, IQ, OQ, validation reports and archiving records /liliMonitor suppliers during the installation of computerised systems /liliEnsure compliance with internal procedures throughout the system lifecycle /liliContribute to internal audits through validation expertise and documentation support /liliCollaborate with IT, Quality Assurance and Operations teams to maintain project compliance /liliAssess system changes and determine their impact on validation status /liliSupport users with system onboarding and troubleshooting /li /ulh3Skills you'll need to bring /h3pTo succeed in this role, you'll demonstrate: /pulliKnowledge of laboratory computerised systems and their lifecycle management /liliUnderstanding of validation documentation, including URS, DQ, IQ, OQ and validation reports /liliFamiliarity with industry best practices and regulatory requirements, including bFDA 21 CFR Part 11, EU GMP Annex 11 and GAMP 5 /b (Good Automated Manufacturing Practice) /liliKnowledge of data integrity principles in GxP environments /liliExperience with change control and validation impact assessments /liliUnderstanding of audit and inspection requirements in regulated environments /liliAttention to detail in the review of compliance and validation documentation /liliAbility to collaborate with Quality Assurance, IT and Operations teams /liliAnalytical approach to troubleshooting and problem-solving /liliUser-focused approach to onboarding and system support /li /ulh3Our commitment to you /h3pFrom day one, you'll have access to a structured onboarding programme and continuous learning opportunities designed to strengthen your technical expertise in analytical sciences. /pulliAccess to advanced laboratory technologies through significant ongoing investment /liliA collaborative scientific culture where knowledge sharing is encouraged /liliA workplace that supports work-life balance and long-term wellbeing /liliThe opportunity to contribute to projects with a direct impact on public health /liliEveryday perks that make a difference: free fitness classes, fresh fruit, up to 4 car washes per year, and practical services like lunch delivery /li /ulh3Who we are /h3h3And why it matters /h3pWe are a Belgian contract research organisation (CRO) based in Thuin, partnering with pharmaceutical companies to deliver high-quality analytical data in line with EMA and FDA standards. /ppSupported 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. /ppJoining us means becoming part of a collaborative environment where scientific expertise is valued, professional growth is encouraged, and every contribution helps advance public health, bcreating lasting value both for our projects and for your career. /b /p