Experience

ADN AxDaNe

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

• Ingénieur consultant validation

  • Oct 2008 - Present



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• outsourcing - VSI consultant

  • 2010 - Present

  [Under Application Manager responsibility / Under Global BSO responsibility since June 2019] Other projects:  Involved in eBRP project, allows the generation and electronic edition of the Batch Release Protocols (BRP) send to health authorities on VDR/MLE sites  Involved in projects related to HP QC / GATE / ALM11 (data migration, UATs)  Involved in PACK (Packaging articles) projects for MLE and VDR, to manage packaging articles inside the LWLIMS  Involved in Shanta (India)… Show more [Under Application Manager responsibility / Under Global BSO responsibility since June 2019] Other projects:  Involved in eBRP project, allows the generation and electronic edition of the Batch Release Protocols (BRP) send to health authorities on VDR/MLE sites  Involved in projects related to HP QC / GATE / ALM11 (data migration, UATs)  Involved in PACK (Packaging articles) projects for MLE and VDR, to manage packaging articles inside the LWLIMS  Involved in Shanta (India) project, LWLIMS deployment on this site.  Involved in the implementation of a Release mode for the changes / incidents implementation following the V6 project upgrade.  Involved in the study for LWLIMS Risks reworking from SW to PUMA methodology.  Involved in the study for implementation of Quality Risks Remediation for SAS analyses.  Process discrepancies identification in preparation for process harmonization between all sites using LWLIMS and potential help for the BioLIMS project  Annual Periodic ITS Users Review management  Involved in the Quality Risk Remediation project, implement several tools to prevent the non update of calculations after inputs modifications: Regression tool / Industrialization tool / Data Cascading.  Instruments interfacing project as IPL (IS Project Leader), creation / upgrade of SWT/TOR instruments interfaces with LWLIMS (Instruments type File Based Data Transfer: File coming from instrument itself or another application ex: Softmax).  Involved as IS Project Leader first, then as Global Business SME (Subject Matter Expert) on eSign Project (still in progress): Replace eSignS web application currently used by LWLIMS eSign Standard, implementation the electronic signature at Results level for Data integrity purpose, harmonized process applicable to all Sites.  Involved as IS Project Leader first, then as Business on CoA phase 2 Project (still in progress): Certificate Of Analyses process enhancement in LWLIMS, more restrictions put in place.

• Outsourcing – VSI consultant

  • Jun 2010 - Jun 2020

  [Under Application Manager responsibility] Continuous maintenance of LWLIMS application since the Go-Lives OASIS : o Support, management, use strategy of Quality center (ALM) o Validation deliverables support, deviations management & support, documentation maintenance o Changes management (change requests / incidents: evaluation, documentation, validation, follow up...) in Sanofi Pasteur tools (TrackWise, Quality Center (ALM), ISeDoc, GeodIS, PROMISE, DEMAT, SNOW…) o TS Writing… Show more [Under Application Manager responsibility] Continuous maintenance of LWLIMS application since the Go-Lives OASIS : o Support, management, use strategy of Quality center (ALM) o Validation deliverables support, deviations management & support, documentation maintenance o Changes management (change requests / incidents: evaluation, documentation, validation, follow up...) in Sanofi Pasteur tools (TrackWise, Quality Center (ALM), ISeDoc, GeodIS, PROMISE, DEMAT, SNOW…) o TS Writing, data creation & support, execution, scripts execution support (IT, UAT, No regression…) & review, deviations management, reports management, preparation of implementations

• outsourcing - VSI consultant

  • Mar 2014 - May 2015

  [Under Application Manager responsibility] Upgrade V6 project, upgrade of LWLIMS application from LabWare V5 to LabWare V6 : o Version upgrade of LWLIMS application, technical upgrade only (no implementation of new business functions) o Validation lead of the operational team o Management or involved in the validation documentation (Validation Plan, Test Strategy, TM, SLA, SCA, DRP, AOM…), management of the complete SIT & UAT phases …

• outsourcing - VSI consultant

  • Oct 2008 - Jun 2010

  [Under VEX / Application Manager responsibility] OASIS project, implementation of a LIMS Labware® solution on Toronto (TOR), Swiftwater (SWT), Val de Reuil (VDR) and Marcy l'Etoile (MLE) sites, validation supported by Quality Center (HP ALM) application: o E2E, UAT, QO test scripts writing & execution o QC training & execution support on site in MLE, VDR and TOR o Deliverables management for and Post GoLives: PPV, UAT & OQ reports, SRV, Final Validation Report