Ludivine RICHARD
INFORMATION SYSTEMS | QUALITY | GxP COMPLIANCE & VALIDATION | DATA INTEGRITY | CYBERSECURITY
36 years old
Driving License
Libourne (33) France
Professional Status
Employed
Open to opportunities
About Me
Welcome on my CV webpage !
You'll find here all information about my professionnal experiences.
Please feel free to contact me if you think that I can support your business.
You can download this CV in pdf format using the icon for that purpose.
You'll find here all information about my professionnal experiences.
Please feel free to contact me if you think that I can support your business.
You can download this CV in pdf format using the icon for that purpose.
CSV Project Leader
Ceva
June 2010
to March 2017
Full-time
Libourne
France
- Computerized Systems Validation
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
Company Description
Pharmaceutical Veterinary Industry