Experience

ADN AxDaNe

• France
• IT Services and IT Consulting
• 1 - 100 Employee

• Computerized Systems Validation consultant

  • Jun 2017 - Present

• Chef du projet agile de mise en place d’un Système de Management de la Qualité (SMQ)

  • Jan 2021 - Jun 2021

  • Planification/revue des sprints • Design, coordination, et intégration dans la suite Atlassian (Jira/Confluence/Xray)

• 3DExperience innovation

  • Nov 2018 - Dec 2018

  • Document Control module validation• Document Control validation package creation• UR, FS, TM revision • Risk Analysis, and Tests revision• Management of the validation activities with the Project Management module of the 3DExperience platform

• Computer System Validation package

  • Dec 2017 - Jan 2018

  • System: the Dassault 3D.Experience platform / "Document Control" module• Collaboration on the Validation package:- URS/FS review- Risk Analysis (associated risks, related regulations, Gravity/Probability/Detectability risks levels, mitigations)- FS_Changes-OQ protocol (elaboration and non formal testing)- FS_Training-OQ protocol (elaboration and non formal testing)



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Documentation Management User Project Leader

  • Jan 2019 - Dec 2020

  Releases / changes management: • Impact Analysis • Revision and update of documentation (Project Plan, UR, FS, Version Release Note, training materials, …) • Coordination of user tests campaigns: authoring of tests protocols, cases and reports, prerequisites management, dryrun, testers training and support, executed tests review, anomaly management, traceability matrix Releases / changes management: • Impact Analysis • Revision and update of documentation (Project Plan, UR, FS, Version Release Note, training materials, …) • Coordination of user tests campaigns: authoring of tests protocols, cases and reports, prerequisites management, dryrun, testers training and support, executed tests review, anomaly management, traceability matrix



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Computer System Validation Expert

  • Feb 2018 - Oct 2018

  • Context : affiliate divestment within very short notice • Systems : 5 GXP applications, 1 non-GXP system • Support, review and approval of quality documents of the project methodology "PUMA", such as: - scoping/go-live phase: project plan (PP), system criticality assessment (SCA), validation plans/reports (VP/VR), users requirements (URS), fonctional and technical specifications (FS, DS), functional risk analysis (FRA), migration plans/reports (DMP/DMR), traceability matrix (TM), authorization for use (AFU) - infrastructure: installation procedures (IP), installation qualifications (IQD, IQF, IQR), architecture specifications (AS) - testing: users (UATs), IT (SITs) Show less



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Computer Systems Quality Qualification/Validation Expert

  • Jun 2017 - Dec 2017

  • Review for approbation of qualification/validation documentation: URS/VP/IQ/OQ/PQ/VR for projects such as : - systems validation/decomissionning, - update of the Change Control Information System ("Phenix") - implementation of serialization and agregation equipment/modules on packaging areas - update of the packaging building inventory - update of the risk analysis guideline • Review for approbation of qualification/validation documentation: URS/VP/IQ/OQ/PQ/VR for projects such as : - systems validation/decomissionning, - update of the Change Control Information System ("Phenix") - implementation of serialization and agregation equipment/modules on packaging areas - update of the packaging building inventory - update of the risk analysis guideline



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• R&D Computer Systems Validation Coordinator

  • Jun 2015 - Oct 2016

  • Tasks: - Compliance Determination - URS elaboration - IQ/OQ/PQ Protocol redaction - IQ/OQ/PQ execution - IQ/OQ/PQ Report redaction - coordination with IT developers, and R&D users • Validated systems : - Excelsheets - SoftMaxPro templates - internally developped softwares (laboratory data analysis) • Tasks: - Compliance Determination - URS elaboration - IQ/OQ/PQ Protocol redaction - IQ/OQ/PQ execution - IQ/OQ/PQ Report redaction - coordination with IT developers, and R&D users • Validated systems : - Excelsheets - SoftMaxPro templates - internally developped softwares (laboratory data analysis)



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Consultant

  • Apr 2014 - Apr 2015

  System Quality Assurance for the New Products Introduction department • Change Control: - oversight / KPIs / Visual Management / archiving GMP docs • Quality Councils: - organisation / preparation / animation / minutes / actions follow-up • Quality Alerts / CAPA Globalization: - analysis and coordination of impacts & answers / actions follow-up • Training Manager: - Local Single Point Of Contact for QA NPI (55 people) / Learning Community activities - training matrix (+ SQIPP impact) - review of Training and Documentation aspects of procedures creation/update Show less



voyage

• Singapour, Australia, New-Zealand

• personnal journey in Oceania

  • Feb 2013 - Jul 2013



Sanofi Pasteur MSD

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Regulatory Data Manager

  • May 2012 - Dec 2012

  • Ensured compliance of the eXtended EudraVigilance Medicinal Product Dictionnary ("XEVMPD") as required by the EMA: - planning: defined and implemented XEVMPD related processes, wrote the associated procedure - developping: analysed and entered products data through the EVWEB interface - checking: QC, verified compliance with source data and regulatory requirements • Ensured compliance of the eXtended EudraVigilance Medicinal Product Dictionnary ("XEVMPD") as required by the EMA: - planning: defined and implemented XEVMPD related processes, wrote the associated procedure - developping: analysed and entered products data through the EVWEB interface - checking: QC, verified compliance with source data and regulatory requirements



Sanofi Pasteur MSD

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Pharmacovigilance Database Coordinator

  • Sep 2011 - Dec 2011

  • Administrated the Global Pharmacovigilance database: - functional management, communication - users support (up to 90 people, 5 sites worldwide) - activities monitoring - training support • Coordinated upgrades and changes in tools and systems within a validated environment: - collaborated with IT and project teams - participated in URS definition - carried out validation tests • Managed incidents and change controls: - risks analysis - problem solving - suggested and implemented corrective and preventive actions (CAPA) - documentation in anticipation of inspections Show less



regional music bands

• Région de Lyon, France

• musical projects (=> one album released)

  • Sep 2010 - Sep 2011

  Participated in several regional music bands projects: - creation - promotion - live performances - 1 album release Participated in several regional music bands projects: - creation - promotion - live performances - 1 album release



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Pharmacovigilance Database Coordinator

  • Dec 2009 - Sep 2010

  • Administrated the Global Pharmacovigilance database:- functional management, communication- users support (up to 90 people, 5 sites worldwide)- activities monitoring- training support• Coordinated upgrades and changes in tools and systems within a validated environment:- collaborated with IT and project teams- participated in URS definition- carried out validation tests• Managed incidents and change controls:- risks analysis- problem solving- suggested and implemented corrective and preventive actions (CAPA)- documentation in anticipation of inspections Show less

• GCP audit activities - Qualit Support Officer

  • May 2009 - Nov 2009

  • Carried out the Quality Control of clinical audit reports:- 120 reports, 37.000 items controlled• Supported continuous improvement:- reviewed documents created by the team (presentations, working instructions, procedures...)- set up quality reviews based on trend analysis of audit results



Bristol-Myers-Squibb UPSA

• production site - Agen (47)

• Quality Assurance Assistant

  • Mar 2008 - Aug 2008

  • Created and implemented a quality dashboard: -140 indicators managed by 26 people gathered in a single automated updatable table • Controlled critical parameters on a production tower: -identification of parameters -checking equivalences with Qualification, Validation and Metrology departments • Created and implemented a quality dashboard: -140 indicators managed by 26 people gathered in a single automated updatable table • Controlled critical parameters on a production tower: -identification of parameters -checking equivalences with Qualification, Validation and Metrology departments



Hospital Hygiene Unit, University Hospital of Grenoble

• Grenoble (38)

• Quality Assurance Assistant

  • Apr 2007 - Jun 2007

  • Assessed the use of a new process for disinfecting equipment and surfaces in 25 services of a 2200 beds hospital: -ran a user survey (84 people involved) -analysed and presented results • Assessed the use of a new process for disinfecting equipment and surfaces in 25 services of a 2200 beds hospital: -ran a user survey (84 people involved) -analysed and presented results