Assurance Quality Expert
il y a 4 jours
Assurance Quality Expert – Computerized Systems (CS/QRM) We are 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 guidelines. Define 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 issues. Supervise outsourced validation activities, including deliverables review, KPIs monitoring, and adherence to internal procedures. Support validation activities across Agile and V-model lifecycle projects. Provide guidance and expertise to teams on Computerized System Validation best practices. Deliver training sessions to internal stakeholders on validation principles and compliance expectations. Conduct initial and periodic risk assessments of computerized systems. Participate in audits, supplier assessments, and provide input during regulatory inspections. Contribute to the implementation and follow-up of corrective and preventive actions (CAPA). Monitor regulatory evolution and assess impacts on CSV processes and documentation. Requirements About You 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. Benefits At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. Our culture fosters audacity, care, and energy, providing a supportive environment that values your talents and encourages growth. #J-18808-Ljbffr
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Assurance Quality Expert
il y a 1 jour
Saclay, Île-de-France Excelya Temps pleinExcelya: 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 ofAudacity, Care, and Energyguide our actions and decisions as we work collaboratively to drive innovation in clinical research.Position...
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Assurance Quality Expert
il y a 1 jour
Saclay, Île-de-France Excelya Temps pleinExcelya: 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...
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Assurance Quality Expert
il y a 1 jour
Saclay, Île-de-France EXCELYA Temps pleinExcelya: 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...
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Assurance Quality Expert
il y a 23 heures
Saclay, Île-de-France Excelya Temps pleinExcelya: 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...
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Quality Assurance Officer
il y a 7 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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Quality Assurance Officer
il y a 1 jour
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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Senior Computerized Systems QA
il y a 4 jours
Saclay, France Excelya Temps pleinA dynamic healthcare organization in Île-de-France is seeking an Assurance Quality Expert specializing in Computerized Systems. In this role, you will ensure compliance and validation according to GxP standards, define risk-based validation strategies, and oversee outsourced activities. Ideal candidates will have a strong background in quality assurance...
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Business System Expert
il y a 1 jour
Saclay, Île-de-France EXCELYA Temps pleinHybridOperations, Statistics & ProgrammingFull timeSaclay, Île-de-France, FranceOVERVIEWDescriptionAbout the JobAt Excelya, we are dedicated to shaping the future of healthcare, and we invite you to be a part of our dynamic team as a Business System Expert. This key position offers you the chance to leverage your expertise to enhance business processes,...
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Business System Expert
il y a 23 heures
Saclay, Île-de-France Excelya Temps pleinAbout the JobAt Excelya, we are dedicated to shaping the future of healthcare, and we invite you to be a part of our dynamic team as a Business System Expert. This key position offers you the chance to leverage your expertise to enhance business processes, drive systems optimization, and support our growth as a leading mid-size CRO.In this role, you will...
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Business System Expert
il y a 23 heures
Saclay, Île-de-France Excelya Temps pleinAbout the JobAt Excelya, we are dedicated to shaping the future of healthcare, and we invite you to be a part of our dynamic team as aBusiness System Expert. This key position offers you the chance to leverage your expertise to enhance business processes, drive systems optimization, and support our growth as a leading mid-size CRO.In this role, you will work...
