NAVA ENGINEERING
Location
Saclay, 91400 | France
Job description
The R&D document management department is looking for a service for the activities listed below.
Summary of the role : Within Global Regulatory Affairs to BE responsible for ensuring conformity of Information Systems with good practices, applying Servier group's document management policies and assisting R&D staff within their business processes and ensure that the validation status of the systems is maintained throughout the lifecycle acting as functional administrator and Business Expert.
Team Management : Manage a team and develop people within the R&D Document Management Department, optimize processes, ensure the oversight of the service provider platform in charge of regulatory SI functional administration.
Functional administration of IS systems :
- Functional administration of the documentary databases
- Follow up of issues, suggest improvements (system and process) in collaboration with users representatives
- Management of evolution and releases as Business expert
- Management of the system validation as Business expert
- Writing of SOP and training materials
- Service provider coordination
- Follow-up of the system validation status, and maintain the system documentation up to date
- User assistance and training management
- Support level 2 for IS administration service provider platform
- Present the system under his/her responsibility during GxP inspection
- Participate into the document/data migration preparation in the context of the set up of a EtoE regulatory solution.
Job tags
Salary