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Il y a 3 heures
Hainaut, Wallonia, Belgique
QUALITY ASSISTANCE S.A.
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pbYour next challenge /bReady to make a difference? Here's what awaits you. /p pAs 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. /p pAs 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. /p pYou 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. /p h3Your
Key Responsibilities
Here's What You'll Be In Charge Of /h3 ul liDefine validation strategies for laboratory equipment computerised systems /li liManage CSV documentation, including its preparation, review and execution, covering URS, DQ, IQ, OQ, validation reports and archiving records /li liMonitor suppliers during the installation of computerised systems /li liEnsure compliance with internal procedures throughout the system lifecycle /li liContribute to internal audits through validation expertise and documentation support /li liCollaborate with IT, Quality Assurance and Operations teams to maintain project compliance /li liAssess system changes and determine their impact on validation status /li liSupport users with system onboarding and troubleshooting /li /ul h3Skills you'll need to bring /h3 h3To Succeed In This Role, You'll Demonstrate /h3 ul liKnowledge of laboratory computerised systems and their lifecycle management /li liUnderstanding of validation documentation, including URS, DQ, IQ, OQ and validation reports /li liFamiliarity with industry best practices and regulatory requirements, including FDA 21 CFR Part 11, EU GMP Annex 11 and GAMP 5 (Good Automated Manufacturing Practice) /li liKnowledge of data integrity principles in GxP environments /li liExperience with change control and validation impact assessments /li liUnderstanding of audit and inspection requirements in regulated environments /li liAttention to detail in the review of compliance and validation documentation /li liAbility to collaborate with Quality Assurance, IT and Operations teams /li liAnalytical approach to troubleshooting and problem-solving /li liUser-focused approach to onboarding and system support /li /ul h3Our commitment to you /h3 pFrom day one, you'll have access to a structured onboarding programme and continuous learning opportunities designed to strengthen your technical expertise in analytical sciences. /p ul liAccess to advanced laboratory technologies through significant ongoing investment /li liA collaborative scientific culture where knowledge sharing is encouraged /li liA workplace that supports work-life balance and long-term wellbeing /li liThe opportunity to contribute to projects with a direct impact on public health /li liEveryday perks that make a difference: free fitness classes, fresh fruit, up to 4 car washes per year, and practical services like lunch delivery /li /ul h3Who we are /h3 pAnd why it matters /p pWe 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. /p pSupported 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. /p pJoining us means becoming part of a collaborative environment where scientific expertise is valued, professional growth is encouraged, and every contribution helps advance public health, creating lasting value both for our projects and for your career. /p h3Team up with us /h3 pQuality Assistance provides the pharmaceutical industry with all the analytical services required by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) regulations for the development and marketing of innovative human medicinal products. /p pWe will make you a key player in our team as we seek to develop the medicines of the future and to speed up people’s access to innovative drugs. /p
Key Responsibilities
Here's What You'll Be In Charge Of /h3 ul liDefine validation strategies for laboratory equipment computerised systems /li liManage CSV documentation, including its preparation, review and execution, covering URS, DQ, IQ, OQ, validation reports and archiving records /li liMonitor suppliers during the installation of computerised systems /li liEnsure compliance with internal procedures throughout the system lifecycle /li liContribute to internal audits through validation expertise and documentation support /li liCollaborate with IT, Quality Assurance and Operations teams to maintain project compliance /li liAssess system changes and determine their impact on validation status /li liSupport users with system onboarding and troubleshooting /li /ul h3Skills you'll need to bring /h3 h3To Succeed In This Role, You'll Demonstrate /h3 ul liKnowledge of laboratory computerised systems and their lifecycle management /li liUnderstanding of validation documentation, including URS, DQ, IQ, OQ and validation reports /li liFamiliarity with industry best practices and regulatory requirements, including FDA 21 CFR Part 11, EU GMP Annex 11 and GAMP 5 (Good Automated Manufacturing Practice) /li liKnowledge of data integrity principles in GxP environments /li liExperience with change control and validation impact assessments /li liUnderstanding of audit and inspection requirements in regulated environments /li liAttention to detail in the review of compliance and validation documentation /li liAbility to collaborate with Quality Assurance, IT and Operations teams /li liAnalytical approach to troubleshooting and problem-solving /li liUser-focused approach to onboarding and system support /li /ul h3Our commitment to you /h3 pFrom day one, you'll have access to a structured onboarding programme and continuous learning opportunities designed to strengthen your technical expertise in analytical sciences. /p ul liAccess to advanced laboratory technologies through significant ongoing investment /li liA collaborative scientific culture where knowledge sharing is encouraged /li liA workplace that supports work-life balance and long-term wellbeing /li liThe opportunity to contribute to projects with a direct impact on public health /li liEveryday perks that make a difference: free fitness classes, fresh fruit, up to 4 car washes per year, and practical services like lunch delivery /li /ul h3Who we are /h3 pAnd why it matters /p pWe 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. /p pSupported 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. /p pJoining us means becoming part of a collaborative environment where scientific expertise is valued, professional growth is encouraged, and every contribution helps advance public health, creating lasting value both for our projects and for your career. /p h3Team up with us /h3 pQuality Assistance provides the pharmaceutical industry with all the analytical services required by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) regulations for the development and marketing of innovative human medicinal products. /p pWe will make you a key player in our team as we seek to develop the medicines of the future and to speed up people’s access to innovative drugs. /p