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Sanofi Pasteur
- Support Validation SI
Lyon
2016 - 2016
Responsable validation SI pour 3 applications :
Nugenesis
EBiobank
Tick@lab
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Sanofi
- SAP Validation Expert
Paris
2015 - 2015
Supporting the Quality/ Validation tasks linked with the solutions maintenance activities (
Validation Plan, Risk Analysis ,Traceability Matrix, Conformity Certificate)
• Updating working instructions ( Change control, Access Management)
• Managing the access to the different SAP Athena Environments
• Supporting the Regional CCS during SAP Athena & SFM deployments and roll-ins.
• Following up the SAP Athena and SFM releases , Validation documentation( Validation Plan,GxP Analysis, UAT Strategy , Traceability Matrix, Technical & Functional Analysis , Version
Release Note, Release Change Control List …)
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Mylan
- IS Validation Leader
SAINT PRIEST Cedex
2015 - 2015
SAP Periodic Review
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Aptar
- IS Validation Leader
Louveciennes
2011 - 2015
My position reports to the IS Compliance and Validation Manager.
I am in charge of defining the Computerized Systems Validation strategy and approach for IS systems (such TrackWise) delivered to the Pharma - Beauty & Home - Food & Beverage - market segments of Aptar and also for the Aptar 1 SAP roll-ins in France, Germany, Switzerland, Italy, Spain, Colombia and North America plants and facilities.
I am administrator of the Document Management System (DMS) : monitoring approval workflows, authorizations and reports for all the IS projects OF all Aptar Group segments in coordination with the IS and Business project managers and Functional Design Management (FDM) Coordinators.
Also in charge to release the non GMP (Good Manifacturing Practices ) relevant Requests for Change (RFC) in Solution Manager System (SolMan) and in TrackWise systems.
For the Aptar 1 SAP roll-ins , I am in charge to monitor the Master Data Migration and Validation / Approvals with the Master Data Migration Team ( MDM Leader , MDM FDM and Regional Key User ) - Trainings are provided to the FDM and Local / Regional Key Users ( Validation and Migration Methodologies )
Main deliverables are : User Requirements Specifications (URS) , Functionnal Specifications (FS) , Validation Plan (VPL) , Installation Qualification Protocol (IQP) , Operationnal Qualification Protocol (OQP) and test forms (OQTF), Performance Qualification Protocol (PQP) and Go Live Decision Report (GDR)
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CVO-EUROPE
- Consultant Validation , Qualification et Qualité des Systèmes Informatisés
LYON
2008 - maintenant
Since 2008,my experience as a Validation consultant in the pharmaceutical industry lead me to command all the validation process, including GMP and 21 CFR Part 11 compliance, on different kind of computerized systems, such as SAP, TrackWise, Documentum and automated systems for production equipment.
I did different projects, in French, English and Spanish for the following customers:AptarGroup,
Sanofi Pasteur, GlaxoSmithKline,Novartis, Mérial, Merck Serono, Ipsen and Mylan France.
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KEZIA
- Manager Qualité
Rillieux la Pape
2008 - 2008
Préparation de l’entreprise à la certification ISO 9001 v 2000 :
Mise en place du Manuel Qualité
Définition des processus majeurs du métier.
Mise en place des procédures « Gestion de projets », « Supply Chain » et « Maintenance »
Définition des indicateurs stratégiques
Animation de formation Qualité – Supply Chain
Mise en place des tableaux de bords et leur suivi.
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VALRHONA
- RESPONSABLE DOSSIER EFQM
Tain-l'Hermitage
2007 - 2007
2007 Responsable du dossier EFQM (European Foundation for Quality Management), Valrhona SAS, Groupe Soparind-Bongrain
Tain l’Hermitage (Drôme)- Stage de fin de Master 6 mois
• Elaboration de l’autoévaluation EFQM de l’entreprise par des audits internes et suivi des principaux indicateurs stratégiques et leur interprétation.
• Responsable du dossier du Prix Européen EFQM de l’Excellence.
• Benchmarking avec différentes filiales du Groupe Soparind Bongrain ;
• Familiarisation avec le concept de l’Excellence, Prix de la Qualité, Certifications et normes (ISO 9000 :2000 - ISO 22000 – ISO 14001- OHSAS 18001) et TPM (Total Productive Management)
• Participation à plusieurs colloques sur l’Excellence et sur le Great Place to Work
• Management de la Satisfaction des Clients et du Personnel.
• Gestion des projets par Microsoft Project.
