Requirements: English
Company: Excelya
Region: Boulogne-Billancourt , le-de-France
Why Join Us? At Excelya, we combine passion forscience with enthusiasm for teamwork to redefine excellence inhealthcare. Heres what makes us unique ! We are a young, ambitioushealth company representing 900 Excelyates, driven to becomeEuropes leading mid-size CRO with the best employee experience.Our one-stop provider service modeloffering full-service,functional service provider, and consultingenables you to evolvethrough diverse projects. Working alongside preeminent experts, youwill help improve scientific, operational, and human knowledge toenhance the patients journey. Excelling with care means benefitingfrom an environment that values your natural talents, pushesboundaries with audacity, and nurtures your potential, allowing youto contribute fully to our shared mission. About the Job JoinExcelya, where Audacity, Care, and Energy define who we are and howwe work. We believe in creating bold solutions and fostering aninclusive environment where collaboration and individual growth gohand in hand. The mission is carried out within the ComputerizedSystems Quality Risk Management Division of R&D QualityAssurance. This division is responsible for ensuring GxP complianceand validation of computerized systems used throughout the R&Dprocess. Main Responsibilities - Manage CSV activities in ClinicalDevelopment, Pharmacovigilance, and Regulatory Affairs, ensuringGxP compliance. - Define validation strategies and review systemdocumentation to support system integrity. - Implement and maintainsystem compliance with standards like GAMP 5 and 21 CFR Part 11. -Apply a risk-based approach to validation, focusing on safety, dataprotection, quality, and reliability. - Oversee outsourcedvalidation, including task definition, deliverable review, andadherence to procedures. - Provide guidance and training oncomputerized system validation to internal teams. - Conduct riskassessments and reviews, and support audits, vendor evaluations,and regulatory inspections. - Implement CAPAs and monitorregulatory changes impacting systems and validation processes. AtExcelya, taking audacious steps is encouraged, so were looking forindividuals who are ready to grow with us and share our values. -Experience: Proven ability to thrive in collaborative, fast-movingenvironments (avoid requiring minimum yearstalent matters most tous!) - Skills: Strong organizational abilities, problem-solvingmindset, and excellent communication skills - Education: Strongknowledge of pharmaceutical regulations, especially GxP standards(GCP, GVP, GCLP, GLP, GMP, RQA). Compliance with CSR (CorporateSocial Responsibility) principles and policies. - Languages:Fluency in English and French, with the ability to contribute tomeetings and create documentation in both languages - Hybrid workmodel: Remote work allowed, but ideally 50% on-site or at least 2days/month at Saclay.