Description

Pharmacien de formation, je me suis spécialisée en gestion de sous-traitance dans le domaine de l'industrie pharmaceutique.

Après avoir travaillé en tant que responsable d'usine pendant 2 ans, j'ai souhaité me concentrer sur les projets tel que les lancements de produit, le transferts et les changements majeurs sur procédé de fabrication existant.

Languages

French
Native or bilingual
English
Fluent

Workplace preferences

Remote only

Primarily works remotely

SANOFI
Project Quality Manager
PHARMACEUTICALS INDUSTRY
June 2021 - Today (5 years)
94250 Gentilly, France
Projects management and audit performance
Technical transfer, product launch, major change on manufacturing process in place (new material source, new equipment, ...)
SANOFI
Project Manager
PHARMACEUTICALS INDUSTRY
October 2020 - June 2021 (8 months)
Prague, Czechia
Projects management and audit performance
Portfolio rationalization, technical transfer, product launch, revision of Annex 1 and local projects
Nominated to 2020 Sanofi Quality Award: Development of digital tool to assess the product tranferability
SANOFI
Quality Associate
PHARMACEUTICALS INDUSTRY
October 2018 - October 2020 (2 years)
Prague, Czechia
CMO management and audit performance
Qualified auditor since Oct 2020 - Scope: API, Solid/Liquid, Sterile, Distribution Subcontractor and CMO management: Deviation, Complaint, Risk, CAPA, Change Control, PQR, Quality site review, Quality agreement, Projects Quality system follow up: subcontractor qualification status, ICHQ3D, ICHQ3C, ICHM7, TSE/TBE, ...

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Doctor of Pharmacy
Université Paris-Sud
2018
Doctor of Pharmacy - PharmD
Master 2 (M2), RMQIS - Responsabilités et Management de la Qualité dans les Industries de Santé
Université de Bordeaux
2018
Master 2 (M2), RMQIS - Responsabilités et Management de la Qualité dans les Industries de Santé

Management Consultant

Laura Kassabi

Pharmaceutical Industry - Quality Expert

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