Xavier Chetaneau
Consultant Expert @fortil
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WORK HISTORY
Consultant Expert @fortil
Montréal, CA
QA CSV et Ingénieur CQV/CSV/Qualité/Conformité
EDUCATION
ESIAB (Ecole Supérieure d'Ingénieurs Agroalimentaire de Bretagne atlantique) [ex ESMISAB]
Diplôme d'ingénieur, Qualité et Microbiologie
IUT Quimper
D.U.T Génie Biologique, Industries Agroalimentaires et Biologiques
ABOUT XAVIER CHETANEAU
Senior CSV & QA Engineer | Biotech & MedTech | Global GxP Compliance | System Validation & Data Integrity ExpertWith over 10 years of international experience in Computerized System Validation (CSV), QA, and CQV, I bring a strong track record in delivering compliant, efficient, and audit-proof systems in biotechnology, medical device, and pharmaceutical environments. From FDA/Swissmedic audits to the deployment of AI validation frameworks From post-market surveillance to managing multi-site GxP validation strategies From lab systems (LIMS, PAS-X, Empower) to enterprise platforms (SAP, Veeva, qTest)I\'ve worked in Highly Regulated GxP Environment, supporting FDA submissions, MDR compliance, and AI system categorization under GAMP 5 and 21 CFR Part 11. Passionate about cross-functional collaboration, pragmatic validation strategies, and regulatory excellence. I thrive in dynamic, high-stakes environments where precision, structure, and leadership are key. Fluent in French, English, Portuguese, and conversational in Spanish. Based in Quebec, Canada – open to global opportunities in regulated industries.Let’s connect if you\'re looking to optimize quality systems, prepare for regulatory inspections, or lead digital validation projects.
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