About Sheeden
French
Native or bilingual
English
Fluent
Experience
- CENEXI CDMOQuality Assurance OfficerPHARMACEUTICALS INDUSTRYDecember 2022 - Today (3 years and 8 months)Fontenay-sous-Bois, France
- **Compliance Management**: Guarantee of compliance with GMP, GDP, and Data Integrity for all analytical activities.
- **Deviation Management**: Expertise in handling non-conformities (Deviations, OOS, OOT) and monitoring corrective and preventive action plans (CAPA).
- **Monitoring & Audit**: Conducting field diagnostics (Flash audits, Housekeeping), active participation in client audits, and regulatory watch.
- **Documentary System & Performance**: Approval and maintenance of quality documentation, change control monitoring, and performance indicator (KPI) management.
- **Training**: Onboarding and skill development of employees on quality processes (GMP, deviation management).
- Laboratoire Servier Industrie GidySystem QualityENVIRONMENTALSeptember 2019 - September 2022 (3 years)Orléans, FranceImplementation of a Quality Management System for ISO 17025 certification;Management of improvement actions (PDCA);Writing and implementation of procedures;Management and handling of non-conformities (5M, CQQCOQP);Document and record management (DMS, EXCEL, Network);Mastery of risk analysis (FMEA);Implementation of Quality and analytical indicators (dashboard).
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Education
- Master double degree in Analysis & Quality AssuranceUniversity of Paris-Est-Créteil2022Master double compétence
- Professional Bachelor's degree in Industrial Quality AssuranceUniversity of Paris Cité & ETSL2020Industrie des Pharmaceutiques, cosmétologiques et de santé : Gestion, production et valorisation - option Assurance Qualité Industrielle
Certifications
- Create and develop a professional training businessUP&COM Certification
Skill set
Categories
- Other