AKKODIS - CSV Engineer - Life Sciences - M/F/X

About the roleThis role involves ensuring compliance with cGMP standards through the validation of computerized systems. You will be responsible for developing and executing validation studies, generating documentation, and maintaining the validated status of systems.This position requires hands-on involvement and technical expertise in validation processes. Ideally, you have experience in the pharmaceutical sector and a strong understanding of quality and compliance regulationsKey responsibilitiesDevelop, implement, and execute validation studies for cGMP-critical computerized systems, regarding URS, SIA, DQ, IQ, OQ, PQ, RV and TM activitiesGenerate validation documentation and assist with protocol execution for computerized systemsEnsure validated status of systems complies with cGMP standards at all timesManage projects in accordance with Sanofi and cGMP regulatory standardsProvide technical assistance on US FDA and EU validation requirements