Charlotte Robuchon

Experience

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  Servier

  Sept 2012 - May 2013

  Responsable Assurance Qualité Thérapeutique
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  AIXIAL

  Jun 2013 - Dec 2014

  Chargé d'assurance qualité thérapeutique

  Validation des SIGestion de la sous-traitance des missions de validationGestion de projets SISuivi d'études clinique, axe rhumatologie

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  Servier

  Jan 2015 - Sept 2022

  Functional administration of the databases *Follow up of issues and improvements *Management of evolution and releases as Business Expert *Follow-up of the system validation status *Redaction of SOP and training materials *User assistance *Management of training *Service provider coordinationImprovement of business process to faster and improve business process by the use of information systemsFlagship projects (new information systems) *Leading operational and steering committee *Writing URS in collaboration with key users *Ensuring contact with IT, Legal, QA staff involved in the project *Ensuring project management follow-upGlobal coordination of service provider team for R&D Document Management Department *Participation in operational and steering committees *Servier contact point with service provider, oversight of the activities outsourced by R&D Document Management Department team and if required prioritization *Definition of new activities to be subcontracted in line with Regulatorya Affairs outsourcing charter and REgulatory Affairs outsourcing department *Improvement of processes between R&D Document Management Department and service provider teams *Maintain updated the subcontracted activities price list quotation in collaboration with Outsourcing Department and Purchase Department, and validate the bill issued by the service provider *Monitoring and improvement of the performance of the service provider (KPI follow-up, management of the deviations, satisfaction survey…) Show less

  • Documentary System Project Manager / Business Expert (Regulatory Affairs)

    Jan 2018 - Sept 2022

  • Chargé d'ingénierie documentaire

    Jan 2015 - Jan 2018
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  Infogene

  Sept 2022 - now

  *Management of project documents*Validation follow up*Support team with migration checks*Creation of SOP*Creation of training support*Communication*System withdrawal*Process improvement *Management of workshops with the editor*Management of project documents*Validation and migration follow up*Creation of SOP*Creation of training support*Communication

  • Project Manager for Clinical Data Repository replacement (Ipsen)

    Feb 2024 - now

  • Project Manager for eTMF upgrade (Ipsen)

    Sept 2022 - Mar 2024