Experience

Quoretex

• France
• Biotechnology Research
• 1 - 100 Employee

• Director Of Operations

  • Jan 2019 - Present



LFB

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Deviations: 3rd Party review

  • 2018 - Present

• iCARE ULIS Manager

  • 2017 - 2018

  Coordination of 4 Quality Engineers involve in closing deviation backlog on Validation/Qualification, Laboratories and plant activities.Assist the global iCARE project Manager (25 Quality Engineers)Categorize current Deviation /CAPA to define backlog action plan and planning.Define new strategies to improve the Deviations Flow and the Quality management in coordination with LFB Plant and AQ Managers.



SEQENS Pharmaceutical Solutions

• France
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QA qualification manager

  • 2018 - Present



Medday Pharmaceuticals

• France
• Pharmaceuticals
• 1 - 100 Employee

• AQ Manager IT Project

  • 2017 - 2017

  QA lead of IT infrastructure and Active directory qualification. QA lead of IT infrastructure and Active directory qualification.



Stallergenes Greer

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• AQ Manager SAP Project

  • 2015 - 2017

  QA Lead of the whole project Manage the team (Up to 6 Validation Engineers) in delivering validation deliverables. Validation of SAP ECC 6.0 system including Manufacturing, Procure to Pay, Warehouse Management , Order Management and interfaces with MES systems. Validate the data migration process for Customer Master, Material Master and Item Master to convert the data from legacy systems into SAP Validation of all SAP specifics developments (report, Certificate of compliance, labels for each products and countries…). Approve Validation Plans, risk analysis, Test Plans, Test Summary Reports, Validation Summary Reports. Define methodology for Hyper Care period after go live. Conduct “root-cause” analysis for software deviations (Gap Analysis), and providing recommendations for the improvements (Mitigation plan). Assist customer for ANSM audits (Back office) Show less



Consult-Up

• Paris Area, France

• President

  • Sep 2000 - Jul 2013

  S.A.S. 38K€ (3 Consultants engineers) Turnover : 300K€ approx. Sales and Business Development Financial & legal transactions Human resources management S.A.S. 38K€ (3 Consultants engineers) Turnover : 300K€ approx. Sales and Business Development Financial & legal transactions Human resources management



CHIMEX (subsidiary L’Oreal)

• Tours Area, France

• General Project Manager

  • 2011 - 2012

  Context and mission: New Product development Implementing units for evapo-concentrator & spray dryer Context and mission: New Product development Implementing units for evapo-concentrator & spray dryer



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Automation Project Coordinator / Senior Consultant

  • 2010 - 2010

  Context and mission: Revamping of biotech units - Providing functional batch analysis - Collecting and follow-up on sub-contractors commercial offers - Set up of Master Qualification/Validation Plan - Development project schedules and budgets according to SP project controls Context and mission: Revamping of biotech units - Providing functional batch analysis - Collecting and follow-up on sub-contractors commercial offers - Set up of Master Qualification/Validation Plan - Development project schedules and budgets according to SP project controls



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Automation Project Coordinator / Senior Consultant

  • 2006 - 2009

  Context and mission: - New building for sterile vaccine packaging • 2 syringes lines, 1 bottle line • Sterile Water, Washing machine, autoclave, HVAC, Clean Room ... - Responsible for the project management of consultants responsible for all automation regulatory compliance activities at client site - Validation of URS, Functional and detail design for the complete building. - Development of integrated commissioning / qualification approach and set up of the whole project for commissioning activities - Development design for optimized electronic reports and qualification approach - Provided operational and technical direction to validation Engineers/Specialists - Managing commissioning (FAT/SAT) and qualification (IQ, OQ, PQ) activities - Ensured that all computer-related validation services were completed with all supporting documentation generated in accordance with the Client policy, SOPs and regulatory requirements - Reporting project status and participation to steering committees Show less



Others experiences

• Consultant

  • 2001 - 2005

  SANOFI AVENTIS – Romainville, France Context and mission: Pharmaceutical/automation consulting EU/cGMP Roles and responsibilities: Quality Automation Project Coordinator / Senior Consultant Duration: 1 year - Revamping of systems of control command - Retrospective qualification Results: - Validation of Functional and detail Automation design - Development of generic commissioning / qualification approach for software upgrade - Writing and follow-up of design, commissioning, validation and exploitation documents - Assisting commissioning (FAT/SAT) and qualification (IQ, OQ, PQ) activities CHIMEX (subsidiary L’Oreal) – Tours, France Context and mission: Process automation and revamping Prospective qualification • Continuous biotech Units (x2 Skids) Roles and responsibilities: Project Coordinator/ Control System Engineer Global Duration: 4 years - Process optimizing automation - Implementing Second unit Results: - Writing and follow-up of design, commissioning, validation and exploitation - Performing complete computer and automation development of Invensys system - Developing specifics programs for batch reports (21CFR Part11) - Performing “on line” sterilisation and CIP for continuous biotech process. RHOM AND HASS - Chemistry - France Context and mission: Automation consulting EU/cGMP Roles and responsibilities: Automation Project Coordinator / Senior Consultant Duration: 2 Years - Audit and risk analysis on global automation activities - Writing main automation plan - follow-up of design, commissioning, validation and exploitation documents Show less



Invensys - Acquired by Schneider Electric

• United Kingdom
• Industrial Automation
• 700 & Above Employee

• technical sales representative

  • 1983 - 2000