o Management of validation projects in the areas covering the life cycle of a drug and support functions (R&D, Pharmacovigilance, Quality Control Laboratory, Production, Quality, IT Infrastructure) o Definition of the validation strategy for each type of computerized system o Organization of schedules, performance analysis of validation projects and recommendation of an optimal organization around the systems in order to reduce the overall validation load o Training, awareness and animation of project teams o Monitoring of all validation projects o Maintaining the validated status of all the computerized systems under my responsibility o Justification of computerized system validation methodologies and presentation of validation files during inspections by authorities o Elaboration of deliverables related to the validation of computerized systems (URS/ validation plan/ risk analysis/ protocols/ tests/ qualification reports/ validation reports/ procedures/ forms/ instructions/…) o Monitoring of new regulations, writing letters, etc. o Audit and evaluation of software suppliers
IT Administration and Support for GxP regulated application
o Resolution of technical problems o Qualification and compliance management of the IT assets used in a regulatory context o Global Empower Administrator o Technical configuration assistance
Support R&D department IT domain management
o Collection and formalization of user needs o Participation in the selection of tools and suppliers of IT solutions o Follow-up and management of the implementation of new solution and evolution of IT tools o Management of services (acquisition/ replacement of computerized systems, qualification execution) o Project delivery planning