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Experiences

Current Experience

  • Quality Support Engineer


    Since May 2015
    Internal Audit Integrated department : Quality Support In charge of : - SOP reviewal (Batch record management, check-lists, Intercampaign, line clearance) - QA compliance : GAP analysis with legal requirements (Compliance ICH / AFMPS / EMEA / Eudralex) and internal standards. - Risk analysis on line clearance specification - Trainings on updated SOP - Coaching for SOP reviewal with new approach planification and follow-up. - Deviation and events management (ex: C&M failure, entry without controlling parameters, wrong documentation) - CAPA management (ex: implemente new visitors follow-up, documentation mapping) - Audit Level 1 (internal audit) on audit process

Past Experience

  • Vendor Quality Support Belgium

    January 2018 --- December 2019
    business

  • Global Quality Support Belgium

    July 2016 --- December 2017
    Change Control

  • Commissioning & Qualification Engineer

    May 2014 --- April 2015
    Documentation

  • Pharmaceutical Engineering Consultant

    April 2012 --- March 2015
    Quality Assurance

  • Quality Assurance Associate

    June 2012 --- May 2014
    GMP

  • Production Engineer

    September 2011 --- February 2012
    Change Control

  • Continuous improvement engineer

    September 2008 --- August 2011
    Food

  • Order Picker

    July 2003 --- October 2009
    Student

  • Assembly Line Worker

    June 2008 --- August 2008
    Medical Devices

  • Production Operator

    May 2008 --- May 2008
    1 month working for maternity leave replacement within the H5N1 flu production. - Mirage of good eggs insertion. - Allantoic fluid recolt. - Cleaning of production area.

  • Storekeeper & Operator

    October 2007 --- April 2008
    Packaging

  • Operator

    September 2007 --- October 2007
    Operator and supplier within the glucose pockets production line.

Knowledge

LinkedIn Assessment :
GMPPharmaceutical IndustryCAPAQuality AssuranceLean ManufacturingEquipment QualificationBiotechnology IndustryProcess EngineeringContinuous ImprovementRoot Cause AnalysisSOPmanagementProject Management21 CFR Part 11Quality SystemEvent ManagementVisual InspectionComplaint InvestigationsBatch recordsSAP ERPSOP

Education

  • Industrial mechanical and production engineer in Industrial Engineering from Institut Supérieur d'Etudes Logistiques (ISEL) (Le Havre - France) in 2011
  • Higher national diploma in IT technology in Industrial software development from High School "La Chataigneraie" (Rouen - France) in 2007

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency
Spanish
Elementary Proficiency

Work Preferences

  • Notice Period:
    1 week
  • Work From Home:
    No
  • Work Regime:
    BrightOwl freelancer :    40 Hours per week
  • International:
    Yes

Area / Region

Bruxelles, Belgium

Others

Driving License
  • Yes

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