À propos de Jean Marc
Computerized Systems Validation Specialist and Lean Project Manager with solid experience in leading cross-functional operational excellence initiatives in the healthcare sector. I integrate frontline insights captured through training delivery, verification activities, and validation processes in collaboration with field engineers. Passionate about innovation, I am eager to leverage my technical expertise and personal strengths to create value. I have a strong interest in the medical device and pharmaceutical industries, particularly in conducting computerized systems validation (CSV) activities, as well as in the qualification and validation of medical devices.
- Biomedical Engineer
- Certified Agile Software Product Owner
- Lean Six Sigma Green Belt
- Professional Scrum Product Owner (PSPO I)
Anglais
Capacité professionnelle complète
Français
Bilingue ou natif
Accepte de travailler sur site
Paris (jusqu’à 50 km)
Expériences
- Ipsen PharmaConsultant Qualité IT - VSIINDUSTRIE PHARMACEUTIQUEnovembre 2024 - juin 2025 (7 mois)Boulogne-Billancourt, FranceProject Title:IT Quality Assurance and Data IntegrityObjectives:
- Ensure compliance of the validation documentation for the systems: ATOLS, COMANDO, GAMS, DATAVISION, and VISION TRACKER
- Conduct periodic reviews
- Validate tools in accordance with GAMP 5 guidelines
Achievements: Review and Approval of All Project DeliverablesReview and approval of system impact assessments, functional risk analyses, validation plans, qualification protocols, test scripts, reports, Go-Live authorizations, qualification and validation in compliance with ISO 13485:2016 and FDA 21 CFR Part 11 Review and Approval of Work InstructionsReview and approval of Change Control requests and CAPA management procedures related to changes implemented directly in production - SanofiConsultant Qualité IT - VSIINDUSTRIE PHARMACEUTIQUEjuin 2023 - septembre 2024 (1 an et 3 mois)Neuilly-sur-Seine, FranceProject Title:Validation of the TraceLink Serialization System and Implementation of a QMS for Serialization ActivitiesObjectives:
- Implementation of a Quality Management System (QMS)
- Drafting and updating of validation deliverables for the TraceLink system
- Validation in accordance with GAMP 5 guidelines
Achievements: Drafting of Validation Deliverables for the TraceLink Serialization SystemDrafting of the validation plan, qualification protocols, test scripts, release plans and reports, qualification and validation in compliance with ISO 13485:2016 and FDA 21 CFR Part 11 Drafting and Updating of SOPs for Serialization ActivitiesDrafting of procedures for Business Continuity Planning (BCP), Change Control, CAPA Management, Incident Management, Monitoring, Audit Trail, User Management, etc. Creation of Work Instructions for the TraceLink SystemDevelopment of detailed work instructions to support system use and compliance Onboarding of CMOs on the TraceLink PlatformCoordination and validation of the onboarding process for 17 Contract Manufacturing Organizations (CMOs) on the TraceLink platform - SanofiConsultant VSIINDUSTRIE PHARMACEUTIQUEjuin 2022 - décembre 2022 (6 mois)Lyon, FranceProject Title:Development of a Website for the Dematerialization of Vaccine Leaflets in a GxP EnvironmentObjectives:
- Ensure compliance of the validation documentation for the ePI (eProduct Information) system
- Drafting and updating of validation deliverables
- Validation in accordance with GAMP 5 guidelines
Achievements: Drafting of All Project DeliverablesDrafting of the validation plan, qualification protocols, test scripts, release plans and reports, qualification and validation in compliance with ISO 13485:2016 and FDA 21 CFR Part 11 Drafting and Updating of Change Management InstructionsDrafting of the Change Control procedure for each type of change (structural/code changes, site initialization, version upgrades, site decommissioning)Creation of a simplified content management procedure via service requests on ServiceNow IT Tool ValidationDrafting of validation deliverables for each release (Agile Scrum methodology with bi-weekly sprints/releases)Drafting and execution tracking of test cases
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Formations
- Ingenieur BiomedicalPolytech Marseille2015
- Sofware Product Management SpecializationUniversity of Alberta2019Introduction to Software Product Management Software Processes and Agile Practices Client Needs and Software Requirements Agile Planning for Software Products Reviews & Metrics for Software Improvements Software Product Management Capstone