Freelancer profile translated to English.
Back to original languageAbout Fanny
Dynamic and committed, I cultivate strong working relationships, based on cooperation, trust, and collective intelligence, in order to transform each mission into an opportunity for shared progress.
Reliability, integrity, and kindness are the foundations of my professional commitment for 18 years in the pharmaceutical industry. I embed these values in an approach focused on innovation, sustainable development, and operational excellence.
My background, rich in experience in quality assurance, qualification/validation, and engineering applied to the design, implementation, and optimization of manufacturing processes, has allowed me to build versatile and recognized expertise. This trajectory positions me as a professional capable of combining regulatory rigor, operational performance, and innovation, in the service of patient safety and compliance with the most demanding standards.
French
Native or bilingual
English
Fluent
German
Conversational
Can work on-site
Strasbourg (up to 50km)
Experience
- Transgene SA • ABL Europe • Oxford BiomedicaIndustrial Operations PilotPHARMACEUTICALS INDUSTRYSeptember 2007 - February 2026 (18 years and 5 months)Strasbourg, FranceCommissioning, Qualification & Validation (CQV) - 6 years- Risk analysis, URS/SoW, FAT/SAT/IQO- IQ/OQ/PQ, periodic qualification, QbD- Protocols/reports, test execution, operational piloting- Management of NC/CAPA/ChangeMajor achievements:- Qualification of areas (VHP, particulate, HVAC, environmental)- Sterilization qualification (sterile filtration, autoclaving, APS)- Equipment qualification (chromatography, TFF, bioreactors, isolators, PSM…)- Process validation (purification, cell amplification)Quality Assurance: 6 years- Quality documentation, NC/CAPA/Change- Data integrity (ALCOA, audit trail, access management)- Remediation plans- ANSM & client audits- Quality indicators, training & authorizationsMajor achievements:- Management of a remediation plan following microbial contamination under Grade A- Complete management of batch records- Commissioning of areas/processes (associated quality documentation)- Deployment of an authorization tracking systemProcess Engineering (USP/DSP – Fill & Finish) - 6 years- Cell & viral amplification- Clarification, micro/ultrafiltration, chromatography- Formulation, sterile filtration, aseptic filling- GMP production of viral vectors, cell banks, VLPsMajor achievements:- Commissioning of a modular USP/DSP area- Deployment of Annex 1 cGMP (isolator, closed systems, sterile filtration)- Design of a generic viral production platform- Industrialization of MV A processes- Development of an aseptic VLP purification process- Automation of chromatographic steps (recipes, data integrity, reports)
- PRISM ExpertisesSenior Industrial Operations ConsultantPHARMACEUTICALS INDUSTRYMarch 2026 - Today (5 months)Strasbourg, FranceA pharmaceutical industry professional for 18 years, I support organizations in their qualification/validation, quality assurance, and process engineering challenges in GMP environments.Reliability, integrity, and kindness structure my way of working. I combine regulatory rigor, operational performance, and innovation to secure processes, strengthen compliance, and optimize production flows.My expertise covers the entire process lifecycle: design, commissioning, qualification, validation, industrialization, and continuous improvement. I work on both strategic projects (Annex 1 deployment, automation, generic platforms) and operational issues (remediation, sterility, data integrity, NC/CAPA).I place central importance on cooperation, transparency, and collective intelligence. My goal: to transform each mission into sustainable progress, serving product quality and patient safety.
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Certifications
- Lean Green BeltICAM2017