Bourgoin, Auvergne-Rhône-Alpes, France
I have started as a chemical process engineer, then have worked in the quality departments of both big and small companies. I have specialized in quality projects and quality management of major pharmaceutical or vaccines companies, and most recently in the software validation of a medical devices company. I am known for my high quality organization and writing skills, whether in English or French. I am eager to share the knowledge that I have acquired and continue to learn. After my different work experiences, I can definitely say I am a fast learner and I am up to every challenge that comes my way.
Quality Assurance Engineer for ResMed
Software validation project leader for ResMed → Assessment of need for different departments * understand the need for the KPIs follow up and assess their relevance * assess the current available database and information * propose improvement in the calculation of the KPIs from a quality standpoint * propose improvement in the use of current database → Design and validation of Excel sheets aimed at calculating the different KPIs * lead validation team and coordinate the project * write validation master plan, risk analysis, user specifications and user acceptance tests
Quality projects coordinator → Set up of a skills matrix for the Life Sciences consultants in agap2
Quality Control Product coordination for GSK (Cervarix vaccine and Adjuvant systems): → Control strategy for vaccine release and stability * perform compendial vigilance assessment for product monographs * implement control strategy changes related to new requirements, line extensions or new destinations * write briefing documents and ensure presentation at Specification Committee * manage changes through change controls for monographs, master data updates, stability strategies, trend analyses → Regulatory support - first file submission for line extension and variation, inspections * write source documents * QC representative in the submission team defining the strategies * review file for QC technical sections * define the response strategy in case of questions → Product Quality Review and Continuous Process Verification * establish the PQR protocols * review list of changes, deviations and CAPAs for the products * perform monthly trend analyses for secondary operations and for stability studies * review monthly trend analyses for primary operations * write stability sections for annual PQR → Product Lifecycle Management * accountable for the management of transversal product deviations * QC representative in Technical Development Team, Technical Lifecycle Team and Task Forces * QC representative in PE/PV assessment, PPQ protocols/reports and Technical Risk Assessment * Support to Cold Chain management (reports and impact assessments) → QC Project Management * evaluate QC workload for lifecycle-products-related projects * prioritize with QC labs → Training/coaching/mentoring of new collaborators
Quality Control Project coordination for GSK: → implementation of a new testing plan for incoming material, using IR and RAMAN technologies * choice of an equipment * follow-up of the validation of the equipment and each concerned raw material with the lab * update of the procedures, monographs and training packages * lead of technical and update meeting, KPI set up and follow-up
Study of the Relations between the Shape of Lacosamide Crystals and the Composition of the Crystallization Medium → Solid State Chemistry (polymorphic form identification,single crystal, cocrystal, granulometry studies) → Solid characterization and physico-chemical analytical methods (XRD, DSC, TGA, FTNIR, RAMAN, Morphogranulometer, Laser granulometry) → Communicating and sharing results (oral presentation, reporting, posters, training/coaching)
Improvement of a catalyst support production process → Investigation, troubleshooting, process development