About Aurore
HOW CAN Aurore HELP YOU🚀?
GxP Expertise | IT Quality
Extensive experience in GxP documentation (author/approver), including impact analysis, URS, Technical & Functional specifications, Risk analysis, Validation plans & reports, test scripts, reports, administration guides, SOPs, and non-conformity management.
End to End Project Lifecycle Management
End-to-end project management from preparation to implementation and stabilization, ensuring alignment with business needs, regulatory standards, and IT constraints.
Stakeholder and Team Management
Cross-functional leadership in an international environment, coordinating vendors, IT, Quality, business, and master data teams.
BI & Data analysis
Collecting, cleaning, and modeling data from various sources.
Analyzing data to identify trends, patterns, and anomalies.
Designing and developing dashboards and reports (using tools like Power BI or Tableau) to visualize insights.
Communicating findings and making data-driven recommendations to stakeholders to support business strategy
PROFIL😊
10+ Years of Experience as a Biomedical Engineer and Data Analyst in medical devices, IT system vendors, and pharmaceutical industries. She has a proven track record of developing expertise in quality, project management, and information systems in an international context.
Senior Consultant & Project Lead for the past 6 years, she has planned, coordinated, and managed IT projects for major clients, including Ipsen, Chanel, Galderma, and Servier.
System Validation Expert for a wide range of regulated information systems (e.g., QMS, LIMS, SAP, Serialisation/Tracelink and Clinical & R&D systems), ensuring projects are delivered through a compliant validation process with all required documentation.
Regulated Environment Specialist with a deep understanding of the rigor and precision required for GxP and compliance.
French
Native or bilingual
English
Fluent
Can work on-site
Paris (up to 40km), Versailles (up to 10km), Saint-Germain-en-Laye (up to 20km)
Experience
- Capgemini Engineering/IpsenProject ManagerPHARMACEUTICALS INDUSTRYMarch 2023 - Today (3 years and 2 months)Boulogne-Billancourt, FranceOpérations techniques - Manufacturing/Supply ChainSAP ( 3PL, eInvoicing) , Artworks, data migration/integration (dans le cadre d'acquistion), MES, serialisation (Tracelink), biometrie (Nymi )- Pilotage de projet du recueil des besoins jusqu'à l'implémentation de la solution en environnement de production- Coordination des différents acteurs/prestataires- Rédaction documentation projet- Surveillance des indicateurs (planning, ressources, livrables, respect des différents process IT)- Méthodologie : agile & cycle en V, résolution de problèmes (5P, QQOQCP, Ishikawa)
- Capgemini Engineering/ServierComputerized System Risk Manager Consultant CAP GEMINI / R&D Quality AssuranceCONSULTING AND AUDITSMarch 2022 - February 2023 (11 months)92150 Suresnes, FrancePérimètre Systèmes d'information R&D - Essais Cliniques:- Implémentation du processus de revue des audits trails (groupes de travail, rédaction SOP)- Revues périodiques de systèmes critiques- Rédaction Analyses de risque- Suivi de projets de validation (Méthode Agile & Cycle en V)- Rédaction Expert Package
- evalu conseilConsultante Qualité & Validation des Systèmes Informatisés - Industrie PharmaceutiquePHARMACEUTICALS INDUSTRYFebruary 2019 - March 2022 (3 years and 1 month)Île-de-France, FranceGestion de projets de validation de différents systèmes d'information (GED, LIMS, MES, QMS, eTMF...) dans plusieurs laboratoires pharmaceutiques, industrie cosmétique, médical device (Galderma, Chanel, Peters Surgical...) Rédaction des différents documents: spécifications, analyse de risque, plan de validation, protocole de QI, QO, QP, plan de test, fiches de test, Suivi et coordination de l'exécution des tests, rédaction des rapports, Matrice de traçabilité, procédure d'administration des systèmes Maintien en l'état validé des systèmes Revues périodiques Réalisation de rapports de migration Rédaction de rapports d'audit (éditeur de logiciels, hébergeur de données de santé).
Recommendations
These freelancer profiles also match your criteria
Agatha Frydrych
Backend Java Software Engineer
4.7
(3)
2
Baptiste Duhen
Fullstack developer
4.6
(4)
5
Amed Hamou
Senior Lead Developer
4
(2)
7
Audrey Champion
Web developer
4.3
(3)
4
Education
- Data analyst, big data, AI, Sciences informatiques et de l''information et services apparentésDataScientest.com2022Data analyst, big data, AI, Sciences informatiques et de l''information et services apparentés
- Master 2 en co-habilitation avec l'INSTN-Institut National des Sciences et Techniques Nucléaires, Génie biomédicalUniversité Nice Sophia Antipolis (membre d'Université Côte d'Azur)2003DESS/Master en co-habilitation avec l'INSTN-Institut National des Sciences et Techniques Nucléaires, Génie biomédical
Certifications
- Green Belt Lean Six sigmaCubik2019