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Samuel LEROUX

Chartres

En résumé

I support quality and performance of pharmaceutical fluids production systems.

I previously worked in production support/ equipment qualification/ process validation/ QA and QC departments, for pharma industry leaders as well as contractors.

As a junior professional, I worked for various areas: environment/ agrochemistry/ lubricants additives and luxury silverware (cutlery).

In student years, I gained exerience from training periods in research and analyses laboratories.

Mes compétences :
Validation
Purified Water
Physical Chemical Analyses
Water For Injection
Aseptic Processing
Clean Rooms
Process Air
Pure Steam
Quality Assurance
Microbiological Analyses
Quality Control
Qualification
Instructions
Commisioning
Deviations Management
Good Engineering Practices
Good Manufacturing Practices
Standard Operating Procedure
Maintenance
Quality Management System
Change Control Management
Preventive Actions
Corrective Actions

Entreprises

  • Novo Nordisk - Clean Utilities Process Engineer

    Chartres (28000) 2017 - maintenant I support the optimization of documentation & processes for Clean Utilities dpt.
  • Novo Nordisk - QA Compliance Engineer

    Chartres (28000) 2016 - 2017 I guarantee that production systems of pharmaceutical fluids and HVAC are routinely operated in compliance with GMP requirements, regarding documentation, change control, deviations and CAPA's.
  • Novo Nordisk - QA Support Engineer

    Chartres (28000) 2014 - 2016 QA Support for Utilities and Project departments:
    - guarantee pharmaceutical fluids systems are operated in compliance with GMPs, regarding daily operation, documentation, change controls, deviations, Corrective and Preventive Actions
    - guarantee pharmaceutical fluids systems are validated in compliance with Corporate SOPS's & GMPs
  • Sanofi Pasteur - Production support engineer

    Val-de-Reuil (27100) 2013 - 2014 - Coordinate environmental PQs of class B/C/D premises and class A laminar flow hood, for B44 formulation building
  • Sanofi - Quality support engineer

    Le Trait (76580) 2012 - 2013 - Coordinate changes controls, for sanofipasteur products filled on the site
    - Write quality suppliers's requirements: primary packagings, disposables and raw materials
  • Sanofi Pasteur - Validation support engineer

    Val-de-Reuil (27100) 2011 - 2012 - Validate the manufacturing of bulk products, for B44 formulation building
    - Implement and execute process PQ
    - Validate measuring techniques associated with process PQ's (homogeneity)
    - Validate cleaning processes
  • GlaxoSmithKline - Validation support engineer

    Notre-Dame-de-Bondeville (76960) 2010 - 2011 - Update criticality analyses of microbiology and physical-chemistry laboratories equipment
  • GlaxoSmithKline - Qualification support engineer

    Saint-Amand-les-Eaux (59230) 2009 - 2010 - Manage PQ's for QC new premises and equipment (project ST07):
    * Utilities: process compressed air (3 networks), purified water production and distribution loop, thermo-regulated rooms
    * Large equipment: decontamination autoclave // sterility test isolator
  • Schering Plough - Validation support engineer

    Hérouville-Saint-Clair (14200) 2009 - 2009 - Technical support for paste products validation
  • GlaxoSmithKline - Validation support engineer

    Notre-Dame-de-Bondeville (76960) 2008 - 2009 - Update validation SOP's and methodologies vs GSK corporate procedures
    - Train engineering, production, maintenance, validation, QA and QC staffs
    - IOQ a fleet of 35 particle counters
  • Sanofi Pasteur - Qualification support engineer

    Val-de-Reuil (27100) 2007 - 2008 - Write and execute IOQ protocols of transfer equipment, for B33 new filling building:
    * mobile vessels
    * automated transfer system : scales, peristaltic pumps, magnetic stirrers, valves
    * aseptic connectors
  • MCA Ingénierie - Qualification support engineer

    Levallois-Perret (92300) 2007 - 2007 -IOQ and HVAC extension for NNE Pharmaplan / LGV Capsules - Dammarie-les-Lys (77)
    - IOQ a cabinet of gas on-line analyzers - NNE Pharmaplan / Air Liquide Santé - Bonneuil-sur-Marne (94)
  • Laboratoires CDM Lavoisier - QC Laboratory senior manager

    La Chaussée-Saint-Victor (41260) 2006 - 2007 - Manage 8 analysts: physical-chemistry, microbiology and animal house testings
    - Analytical release products, raw materials and packagings in Navision
  • Cardinal_Health - Validation engineer

    Neder-Over-Heembeek / Belgium 2005 - 2006 - Follow up initial environmental qualifications of premises and utilities
    - Validate cleaning processes of formulation and filling equipment
  • Cardinal_Health - QC laboratory senior manager

    Osny (95520) 2004 - 2005 - Manage 1 QC deputy and 27 analysts in charge of physical-chemical testings
    - Analytical release products, raw materials and packagings
  • Ethypharm Industrie - QC laboratory senior manager

    Le Grand-Quevilly (76120) 2002 - 2003 - Manage 2 QC supervisors and 10 analysts (physical-chemical testings)
    - Analytical release products, raw materials and packagings in Protéan
  • Pharmacia - Fine chemicals QA head

    Val-de-Reuil (27100) 2001 - 2002 - Manage 3 QA unit engineers: manufacture batch review, products specifications and quality incidents
    - Release API's in BPCS
  • Thépenier Pharma Industrie - QA/AC deputy

    Saint-Langis-lès-Mortagne (61400) 2000 - 2001 - Control and release packagings in Prodstar
    - Write site Standard Operating Procedures
    - Validate cleaning processes for the manufacture of paste, liquid and dry products
  • Lubrizol - Analyste laboratoire

    Rouen (76000) 2000 - 2000 - Perform physical-chemical analyses of additives for lubricants
  • Orgachim - Production engineer

    Oissel (76350) 1998 - 1999 - Manage a team of 4 operators in week-end shift
    - Manufacture an organic intermediate for the synthesis of a preventive fungicide
  • Gester - Environmental supervisor

    Le Grand-Quevilly (76120) 1998 - 1998 - Supervize clean-up activities on a site of former high furnaces
  • Propharm'Aix Industrie - Validation engineer

    Rousset (13790) 1997 - 1997 - Validation nettoyages production
  • Yacco - Trainee engineer

    Saint-Pierre-lès-Elbeuf (76320) 1992 - 1992 - Perform physical (rheology) and chemical analyses of high standard lubricants
  • Laboratoire Crépin Rouen - SGS Qualitest - Trainee technician

    Rouen (76000) 1991 - 1991 - Perform analyses of organophosphorous pesticides with Gas Chromatography
  • Lancashire Polytechnic - Trainee technician

    Preston / United Kingdom 1990 - 1990 - Perform organic syntheses and characterization with IR, fluorescence and H1 NMR

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