Freelancer profile translated to English.

Description

Quality Consultant specializing in document management and digital QMS, with solid experience in demanding pharmaceutical environments.

I intervene in organizational, documentary, and digital missions: writing and updating procedures, managing the document lifecycle, structuring the quality system, user support, and documentary preparation for audits.

Industry field of expertise

Languages

French
Native or bilingual

Workplace preferences

Remote only

Primarily works remotely

EUROAPI
Quality Consultant - Quality System (QMS) & External Manufacturing Support
PHARMACEUTICALS INDUSTRY
October 2022 - September 2023 (11 months)
- Writing and updating quality procedures (SOPs, operating procedures)
- Document lifecycle management (creation, revision, archiving)
- Support for the deployment of eQMS processes
- Monitoring of quality indicators (weekly/ monthly / quarterly)
- Participation in documentary preparation for audits and inspections
- Quality support for External Manufacturing activities (CMOs)
QMS GMP/GDP Document Management User Support KPI Management
SANOFI
Quality Consultant - Risk Analysis
PHARMACEUTICALS INDUSTRY
February 2020 - December 2020 (10 months)
- Performing Risk Assessments related to nitrosamines
- Analyzing and consolidating data from suppliers and CMOs
- Writing risk assessments according to internal guidelines
Risk Management
Sanofi Pasteur
Formulation Workshop Support Consultant
PHARMACEUTICALS INDUSTRY
June 2019 - December 2019 (6 months)
- Documentary review of batch records
- Monitoring of documentary deviations and anomaly reporting
- Quality management and archiving of batch records
- Monitoring of consumption and associated transactions
- Interface for production/quality departments for documentary consolidation