Thiverny
Analytical skills
-Transfer of analytical methods (as donor and receivor)
-Validation of analytical methods
-Statistical evaluation for settings of specifications and limits
-Qualification of new product references
Stability handling (clinical and commercials) of Drug Products (vials and syringes forms) and Drug Substances.
-Redaction of stability reports and protocols (based on ICH guidelines)
-Statistical evaluation of shelf life of Drug Substances
Quality and compliance
-Approval of analytical data (HPLC, CE-SDS, SDS-PAGE, Assay by UV, ELISA) of IPC (In process Control), release and stability analyses
-Handling and investigation of deviations, OOE and OOS results. Realization of CAPA (Corrective and preventives actions)
-Handling and realization of Change Controls
Regulatory Knowledge
-Review of CTD/IND/IMPD documents
-Answers to Health Authorities during submission
-Active participation to Health Authorities inspections (FDA, ANSM, ANVISA)
Green Belt Certified
QC organization and management
-Organization of QC transversal process
-Redaction and review of SOP
April-September 2010: 6 months internship in the development laboratory of polymers deformulation of Rhodia in Lyon (France) to develop and validate analytical methods (HPLC and GC).
June-October 2009: Internship in Akzo Nobel in the Netherlands (Arnhem) to optimize analytical methods (Raman) and statistically study the impact of different parameters (impurities, pH, temperature) on the titration.
Mes compétences :
Biotechnologies
Chimie
Chimie analytique
Chimiste
Contrôle qualité
CPG
GMP
HPLC
Qualité
Raman
Recherche