Description

Faten | CSV Expert

With 5 years of experience in Computerized System Validation (CSV), I provide end-to-end validation services ensuring system integrity and compliance with regulatory standards like FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. I offer meticulous documentation and risk mitigation strategies tailored to your needs, ensuring timely delivery and client satisfaction. Let's collaborate to optimize your systems and ensure regulatory compliance.

Why Choose Me:

Extensive Experience: With 5 years of hands-on experience in CSV, I bring a wealth of expertise to every project, ensuring smooth and efficient validation processes.
Attention to Detail: I prioritize precision and thoroughness in every aspect of validation, meticulously addressing compliance requirements and system intricacies.
Timely Delivery: I understand the importance of project deadlines and strive to deliver results promptly without compromising on quality or accuracy.
Client-Centric Approach: Your satisfaction is my top priority. I maintain open communication channels, listen attentively to your needs, and tailor my services to exceed your expectations.

Services Highlights:

Regulatory Compliance: Stay ahead of regulatory changes and ensure ongoing compliance with industry standards.
Risk Management: Identify and mitigate potential risks to enhance system reliability and security.
Validation Documentation: From validation plans to final reports, I provide comprehensive documentation to support your validation efforts.

Let's Collaborate!

Whether you're in the pharmaceutical, healthcare, or any other industry requiring CSV expertise, I'm here to support your validation needs. Let's collaborate to optimize your systems, streamline validation processes, and ensure regulatory compliance.

Feel free to reach out to me. I'm eager to discuss how I can assist you with your CSV projects and help you achieve your validation goals!

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent
Arabic
Native or bilingual

Workplace preferences

Can work on-site

Messimy (up to 50km)

institut George Lopez
Chargé validation des systèmes informatisés
PHARMACEUTICALS INDUSTRY
August 2022 - Today (3 years and 9 months)
Lissieu, France
Gérer les releases des systèmes en place
Collecter les URS pour la mise en place de nouveaux systèmes ou amélioration des systèmes existants²
Valider les systèmes informatisés (logiciels et SI intégrés dans des équipements) en respectant les étapes du cycle en V
Améliorer le processus de validation et rédiger les procédures manquantes
Elaborer et piloter les revues périodiques
Supporter les entités sur leurs activités de validation
CENTRE OSCAR LAMBRET
Validation d’un CRF (Ennov Clinical)
MEDICAL
December 2020 - June 2021 (6 months)
Lille, France
Former les participants en analyse de risque
Former les utilisateurs en l’exécution des tests dans un environnement règlementé
Elaborarer les protocoles de QI, QO, QM et QP en se basant sur une stratégie de validation et une analyse de risque
Piloter les Tests
Rédiger le Rapport de validation final
Sanofi Global
Buisness system owner (phenix)
PHARMACEUTICALS INDUSTRY
June 2021 - August 2022 (1 year and 2 months)
Lyon, France
Gérer les releases (Change contrôle pour maitriser le changement)
Exécuter des tests et détecter les anomalies à corriger
Rédiger les Users acceptance tests pour vérifier la non regression des fonctionnalités suite aux nouvelles releases
Rédiger le rapport de validation
Supporter les utilisateurs
Mettre à niveau les procédures
Rédiger les users story pour le nouveau quality management système