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Experiences

Current Experience

  • Quality Support Engineer
    Since May 2015
    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

  • Commissioning & Qualification Engineer
    May 2014 --- April 2015
    Integrated project : Project WN201 - Inactivated Polio Vaccine. Integrated package : Media & Buffer. Equipment : Vessels (Preparation & Hold/Distribution), Filters, CIP/SIP skid, Clean/Black Utilities. Operation Tool used : Delta V. In charge of : - Test sheet preparation for IV/OV in the mechanical department. - Test execution for IV/OV in the mechanical department. - Test sheet review for IV in the mechanical department. - Safety management : Daily safety meeting with subcontractors to communicate on tests/activities with potential risks and safety measures. - Subcontractor documentation review : Isometrics/piping & instrumentation drawing/data sheets review, update and superseed.

  • Pharmaceutical Engineering Consultant
    April 2012 --- March 2015
    As a Pharmaceutical Engineering Consultant for Altran, I had the opportunity to work as : - Quality Assurance Associate for Janssen during 2 years. - Commissioning & Qualification Engineer for GSK during 10 months. See below experiences for more details.

  • Quality Assurance Associate
    June 2012 --- May 2014
    Context : New EDC (European Distribution Center) for cold and ambiant drugs. GMP activities start followed (repackaging & visual inspection). Tool used : Trackwise, PQMS, SAP. In charge of : - Provide support for operational non conformities : damages, impact assessment on temperature excursion, mix-up investigation, quantity discrepancy investigation. - Perform operational QA activities : quarantine shipments, batch split, sampling request. - Manage the GMP activities (visual inspection & repackaging) : batch record approval & review. Follow-up and support during GMP activities. - Event / deviation / complaint management : creation, criticality review, initial impact assessment, final impact assessment, investigation, CAPA, follow-up with manufacturer and affiliates, closure. - Analyse potential improvement points. - External audit : preparation and support

  • Production Engineer
    September 2011 --- February 2012
    Within an antibiotic filling and packaging department, my main missions were: - To ensure that batch records were sent to the QA department on GMP compliance reviewing batch records of intermediates & final drug - To support the day-to-day activites in the Manufacturing team following-up deviations, change control, CAPA and failure investigations

  • Continuous improvement engineer
    September 2008 --- August 2011
    Within a new services department of food production mechanic as heat exchanger, pumps or valves, I was in charge of the implementation of a lean improvement way of work and proposal of improvement actions : - Visual management: dashboard implemented - IT improvement e.g. creation of a new services database with services follow-up, new planning tool, receiving form and traceability sheet - 18 % of production cost reduction - Team managed within a services department and within customer’s sites

  • Order Picker
    July 2003 --- October 2009
    Part time and student work (week-ends and school holidays) into the distribution center of Intermarché, I was in charge of the : - picking of cold products. - picking of ambient products. - products paletization. - trucks loading.

  • Assembly Line Worker
    June 2008 --- August 2008
    Working for 3 month in the night shift within assembly department for medical devices (spray devices). - Line supply for packaging article. - Waste evacuation. - Sampling management. - Defects resolution.

  • 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
    - Operator into the secondary packaging line for Fluocaril products. - Storekeeper for repackaging/labelling/relabelling areas. - Storekeeper for safety individual protection.

  • 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