Assurance Quality Expert
il y a 5 jours
Excelya: Your Future Starts HereAt Excelya, we pride ourselves on being a leading mid-size Contract Research Organization (CRO) with over 900 passionate professionals dedicated to improving healthcare. Our core values of Audacity, Care, and Energy guide our actions and decisions as we work collaboratively to drive innovation in clinical research.Position Overview:We are currently looking for a knowledgeable and detail-oriented Quality Assurance Expert specializing in Computerized Systems (CS/QRM) to join our dynamic quality assurance team. In this role, you will be instrumental in ensuring the compliance, quality, and effectiveness of our computerized systems and the associated quality risk management processes.Main Responsibilities:Ensure compliance and validation of Computerized Systems in alignment with GxP requirements and internal guidelinesDefine and implement risk-based validation strategies based on system criticality (data integrity, patient safety, product quality)Review existing validation documentation and oversee proper management of deviations or issuesSupervise outsourced validation activities, including deliverables review, KPIs monitoring, and adherence to internal proceduresSupport validation activities across Agile and V-model lifecycle projectsProvide guidance and expertise to teams on Computerized System Validation best practicesDeliver training sessions to internal stakeholders on validation principles and compliance expectationsConduct initial and periodic risk assessments of computerized systemsParticipate in audits, supplier assessments, and provide input during regulatory inspectionsContribute to the implementation and follow-up of corrective and preventive actions (CAPA)Monitor regulatory evolution and assess impacts on CSV processes and documentationAbout YouWe are looking for candidates with a strong background in quality assurance and computerized systems:Experience: Strong experience in quality assurance with a focus on computerized systems validation in the pharmaceutical or biotechnology sector.Skills: Strong knowledge of GxP regulations (preferably GCP, GVP, GCLP, GLP, GMP) and proven experience in Computerized System Validation and compliance in a regulated environment.Education: Bachelor’s degree in Life Sciences, Computer Science, or a related field.Languages: Proficiency in both English and French is required.Why Join Us?At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. Here’s what makes us unique We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey. Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission. #J-18808-Ljbffr
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CS Quality Assurance Expert – Computerized Systems
il y a 5 jours
Saclay, France Excelya Group Temps pleinA leading Contract Research Organization is seeking a Quality Assurance Expert specializing in Computerized Systems to ensure compliance and quality. The ideal candidate will have strong experience in quality assurance, knowledge of GxP regulations, and a Bachelor’s degree in a relevant field. Proficiency in English and French is required. Join us to...
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Quality Assurance Officer
il y a 3 heures
Saclay, Île-de-France EXCELYA Temps pleinAbout the JobAt Excelya, we take pride in embodying the core values of Audacity, Care, and Energy. As a leading player in the healthcare sector, our mission is to ensure quality and compliance in all our clinical research operations.This mission is part of a strategic "Data Integrity Enabling Program" aimed at strengthening data governance and ensuring full...
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Aq Officer
il y a 4 jours
Saclay, France Excelya Temps pleinJoin Excelya as a **Documents Qualités (SOP) et Archivage Specialist**, where you will play a key role in ensuring our quality management systems are effective and compliant. In this position, you'll be responsible for the creation, updating, and control of Standard Operating Procedures (SOPs), as well as archiving practices, to support the smooth operation...
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Data Manager CMC
il y a 5 jours
Saclay, France Excelya Group Temps pleinWhy Join Us? At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact. As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service...
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Data Owner support
il y a 5 jours
Saclay, France Excelya Group Temps pleinAbout the Job Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team in Data Management. You will play a critical...
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Data Manager CMC
il y a 1 semaine
Saclay, Île-de-France Excelya Temps pleinWhy Join Us?At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service...
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Data Governance Owner
il y a 2 semaines
Saclay, Île-de-France Excelya Temps pleinAbout the JobJoin Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.This role is an exciting opportunity to contribute to a dynamic, ambitious team in Data Management. You will play a critical...
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Data Governance Owner
il y a 2 semaines
Saclay, Île-de-France EXCELYA Temps pleinAbout the JobJoin Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.This role is an exciting opportunity to contribute to a dynamic, ambitious team in Data Management. You will play a critical part...
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Data Owner support
il y a 7 jours
Saclay, Île-de-France EXCELYA Temps pleinHybridOperations, Data ManagementFull timeSaclay, Île-de-France, FranceOVERVIEWDescriptionAbout the JobJoin Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.This role is an exciting opportunity to...
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Data Governance Owner
il y a 5 jours
Saclay, Île-de-France Excelya Temps pleinAbout the JobJoin Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.This role is an exciting opportunity to contribute to a dynamic, ambitious team in Data Management. You will play a critical...
