Greater Nice Metropolitan Area
Bachelor in Chemistry, completed with a Master’s degree in Quality Management. I began my career in 2007 as an Analytical Chemistry R&D Specialist in New Drug Development at Pierre Fabre Laboratories. I then joined Shadeline (Anjac Health & Beauty Group), working in cosmetics and Class I & IIa Medical Devices, where I served as Quality Control Manager for eight years. In 2017, I joined GE Healthcare as a QA Production & Process Control Engineer.
- Production Quality Responsible - QA Core Team member for Design & Development in Medical Device NPIs, fully involved in Design Controls deliverables, including: .Integrated Development Planning .Design Inputs .Design Outputs .Design Verification .Design Transfer - QA Core Team contributor for Design & Development changes, for both NPIs and Installed Base (IB) products. -Active participant in Quality Management Reviews, covering Design Controls and Manufacturing aspects. - Contributor to CAPA Reviews, with a strong focus on: .Manufacturing internal Non‑Conformities .Findings from external & internal audits .NPIs development–related issues
Experience Summary – Quality & Analytical Development : Quality professional with strong experience in analytical development, regulatory compliance, and laboratory management across dermo‑cosmetics, OTC products, and Medical Devices. Skilled at working in certified environments and leading cross‑functional activities involving Quality, Production, and R&D. Skills & Achievements : 🔹 Technical support for analytical development Contribution to analytical method optimization, project support, and method validation activities. 🔹 Audits & regulatory compliance : Active participation in Client and Certification audits. Key contributor to achieving ISO 13485 certification and maintaining GMP/GLP – ISO 22716 compliance. 🔹 Quality System Management : Authoring and updating quality procedures. Management of batch records, batch release, nonconformity follow‑up, and CAPA management. Strong involvement in continuous improvement initiatives for quality and processes. 🔹 Laboratory management : Oversight of analytical testing on raw materials, bulk products, and finished goods in dermo‑cosmetics, OTC, and Medical Devices. Management of laboratory equipment, consumables, and metrological follow‑up. Equipment qualification and preparation of Certificates of Analysis. 🔹 Leadership & team coordination : Supervision of a Quality Control technician and facilitation of cross‑functional collaboration between Quality, Production, and Development teams.
- Développement et validation de méthodes par HPLC et Potentiométrie. - Suivi de stabilité des produits finis pharmaceutiques. - Analyses HPLC et UPLC . - Analyses CPG inj. seringue ou Head-space . - Test de dissolution - Analyses par spectrophotométrie UV et IR . - Entretien et maintenance. - Qualification annuelle sur HPLC. Compétences techniques : HPLC : Waters Alliance 2695, Dionex U3000, HP Agilent 1200, UPLC Waters, Perkin S200 CPG : HP Agilent . Techniques analytiques : Potentiométrie, pHmétrie, Karl-Fisher, Réfractométrie, Minéralisation, Spectrophotométrie de flamme, UV et IR . Logiciels : Word, Access, Excel, Power Point, Chemdraw, Validation Manager, CHROMELEON, HP, EMPOWER, TOTALCHROM & CHROMERA.