Gwenaelle Le Roux

- Process analysis (process map, FMEA, 5S, root cause analysis). - Investigate new system enhancements and prepare business case documents. - Take a leadership role in system enhancement implementation to ensure business needs are fulfilled.

- Writing of the High Level Validation documentation (Validation Master Plan/ Business Continuity Plan/ 21 CFR Part 11 Compliance assessment) - Quality Control of the validation strategy and documentation (Change Control/ Statement of Work/ Risk Management /Validation Plan/ Specifications/ Verifications : unit test, IQ, OQ, PQ) - Follow-up of the quality reports - Involvement in the internal, external and regulatory audits - Follow-up of subcontractors - Involvement in the Lean Sigma projects

Computerized System Validation projects in Pharmaceutical Industries. MDS Pharma, Baillet ; PPG, Angers, Novo Nordisk, Chartres ; Aventis Pasteur, Val de Reuil ; Aventis Pharma, Sceaux ; Novartis Pharma, Huningue ; Sanofi Synthélabo, Aramon ; Janssen Cilag, Val de Reuil : Sanofi Synthélabo, Chilly Mazarin ; Alcon, Kaysersberg - Compliance project management (GMAO, SCADA, Laboratory equipment, database, HVAC..) - Writing of validation documentation (risk analysis, validation plan, protocol and tests rep

- Writing and execution of the equipment qualification tests (production lines, production equipment, HVAC, purified and demineralized water..) - Writing of operating instructions and procedures

- Qualification of a chemical pilot plant (production equipments, HVAC, purified and demineralized water).

Health Engineering

Biology