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Actelion
- Senior CSV QA Manager
Paris
2008 - maintenant
- Manage one person
- Provide assurance that GxP regulated computerized systems are suitably implemented and managed in accordance with Actelion requirements and, where appropriate, in accordance with regulatory requirements
- Provide support, guidance and advice with regard to computerized system validation within GxP area, 21 CFR Part 11 and EU GMP Annex 11
- Provide support, guidance and advice with regard to IT Infrastructure qualification to comply with GxP requirements
- Determine regulations that are applicable to a computerized system and need for validation
- Apply advanced knowledge and experience to address complex issues
- Review and/or create validation documents where appropriate
- Act as a primary contact person between the computerized system project team and GQM
- Act as the GQM representative with regard to the update of the internal computerized systems inventory
- Perform and coordinate internal and external audits (e.g., vendor audit…) with regard to Computerized System Validation
- Perform and coordinate internal and external audits with regard to IT Infrastructure and services qualification
- Perform and coordinate internal and external audits with regards to IT infrastructure and services qualification
- Agree on Corrective/Preventive Actions following audits and follow up on adequate execution
- Perform vendor postal assessment
- Prepare audit plan and Validation Master Plan
- Manage QS Documents relating to CSV QA activities
- Manage internal tool(s) supporting CSV QA activities (electronic tool(s))
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Assystem
- Ingénieur Qualité / Validation SI
Courbevoie
2007 - 2008
SANOFI-AVENTIS:
- Creation of a new Quality system. Drafting quality documents as Procedures, Operating Manuals, Forms, Models in line with regulatory rules (GXP, SOA…)
- In charge of Quality Control for a computing service (Responsibility for Change Control Process, Access management, documentation management..)
- In charge of Central Validation during Project implementations (Audit Trail for example). Drafting quality documents as test cases of Operational Qualification, project plan, test plan, system conformity certificate, release into production statement.
- Animation of the Quality meeting between the computing service and the production plants
- Coordinator Disaster Recovery Process between the computing service and the production plants
SANOFI AVENTIS:
- Drafting Installation and Operational Qualification Procedures for equipment (COT-mètres)
- Drafting Operational Qualification Procedures for the validation of a computer system (SEPC)
- Drafting a Procedure and an Operating Manual to use VHP equipment (VHP1000 et VHP 1001)
ASTRA-ZENECA:
- Verification of the correct suppression of information in the SOSI system during Operational qualification of SAP
GENOPOLE:
- Drafting Installation and Operational Qualification procedures for different activities (Special gas, GTC…)
PROCTER & GAMBLE :
- Participation in the HVAC system Qualification
- Realisation of the Installation Qualification
- Drafting Operational Qualification test cases
- Realisation of the Operational Qualification test cases
Trained on :
GEODE, ASK-IT, SIMPLe, GMP/GLP, 21 CFR Part 11, HVAC
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Assistance publique - Hôpitaux de Paris
- Responsable Assurance Qualité
Paris
2007 - 2007
- Implementation V2 rule in the Hospital
- Animation of the Quality meeting
- Implementation by improvement axes, risk management, the coverage and the route of the patient, the hotel and logistic functions, the management and the strategic orientations, the evaluation of the professional practices…
- Creation of a data base to centralize all the quality documents of the hospital.
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LVMH - Parfums Christian DIOR
- Assistant Responsable Assurance Qualité
Paris
2006 - 2006
Rattachée au sein du Laboratoire de Toxicologie in vitro, ma mission principale était de mettre en place l'arrété du 10 aout 2004, à savoir les Bonnes Pratiques de Laboratoire. Cette mission m'a permis de créer différents processus (Qualification du personnel, Qualification des équipements, validation informatique, Gestion des réactifs), de mettre en place ces processus par le biais de procédures et de formations (au sein du laboratoire et de l'entreprise). En tant que chef de projet, je formais 4 techniciennes sur ce projet. Cette mission donnera lieu à un audit par l'Afssaps.
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SENOBLE
- Assistant Ingénieur production
JOUY
2005 - 2005
Indépendante dans mon travail, ma mission consistait à optimiser le process des yaourts étuvés et des yaourts brassés produit par l'entreprise. Ceci comprenait, la recherche des pertes matières, la proposition de solutions et la mise en place de ces dernières en incluant les notions qualité. Cette mission m'a permis de travailler au coeur du process et de mettre en place certains outils de l'Amélioration continue.
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Conserverie C. Derungs
- Assistant Ingénieur production
2004 - 2004
La mission qui m'avait été confiée, était de mettre un place un nouveau processus de jus de fruit pétillant. Cela consistait à comprendre un nouvel équipement, réaliser des tests produits et consomations, former le personnel sur l'équipement et le nouveau process. Cette mission a représenté 3 mois de travail.
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DIAGNOSTICA STAGO
- Assistant Ingénieur Qualité
Asnières-sur-Seine
2003 - 2003
Au cours de cette mission mon objectif était de créer les dossier de gestion de risque de tous les équipements produit par l'entreprise. Ce travail m'a permis de découvrir et mettre en pratique les normes NF EN ISO 13485 et 14971.
