Quality Assurance
Sanofi
Total years of experience :12 years, 5 Months
o Cleaning Validation at Sanofi, QA coordinator Qualification/Validation, January 2014 until now
Cleaning validation on biotechnological equipments for Monoclonal Antibodies
QP for buffers and media
Sanitization and storage of columns and ultrafiltration and diafiltration cassettes
QP washing machine
Lead investigations for Deviations
Nov 2011- Dec 2013 Process Validation at Merck MSD, Global Technical Operations, 2 years and 2 months
Process validation (increase of a batch size, removal of parabens), organization of trial, organization of sampling and analysis of results;
Impact analysis for noncompliance, writing validation plan, protocols and reports (sterile and non-sterile unit)
Cleaning Validation on new equipment and periodic evaluation
Head Project for the implementation of Continued Process Verification (CPV): consultation of suppliers; call for tenders; writing specifications; research of adapted software for the computerization of the documentation system and the collect of critical process parameters (CPP/CIPC)
Implementation of Proactive Process Analysis Plan (PPA)
Investigation process (Ishikawa, 5 whys, brainstorming, task force)
April-Oct 11 LFB (Biotechnology and Fractionation Laboratory), France, process development, 6 months
Nanofiltration assay
Optimization of chromatography by replacing a gel
Screening and analysis of results by DOE
Programming chromatographic methods on Unicorn (Akta Purifier/Akta Avant)
March-Oct 10 Sanofi-Aventis, France, biotechnology unit, 8 months internship
Analysis of the shelf life of chromatographic gels used in industrial purification
- Research of new performance criteria (physicochemical and hydrodynamic)
- Elaboration of a pluri-annual and auditable plan for replacing gels
Interpolation of a purification process of a recombinant protein for a future industralization
- Programming chromatographic methods (Akta Explorer, Akta Pilot)
- Achievement of the process at lab scale (centrifugation, UF, NF, DF)
- Initiation of operators to the purification process
July-August 08 HAYAT Pharmaceutical Industries, Jordan, Quality control department (QC), 2 months internship
Physical and Microbiological tests on tablets
July-August 07 French Health Products Safety Agency (AFSSAPS), France, biotechnology and biochemical of proteins department, 2 months internship
Growth hormon analysis by HPLC and mass spectrometry
2005 - 2010 Ecole de Biologie industrielle Process and quality engineering in pharmaceutical industry
2003 Sonia Delaunay High school, France Scientific A-level specialized in Physics and Chemistry