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Summary

Working into RA position, I improve every day my organisation skills and business management. Dedicated to my work, workload is my motivation and I'm not afraid of the quantity. My positive stress in critical situations allow me to work more efficiently. I'd like to develop and improve my knowledge and skills into a worldwide pharmaceutical company by being involve in new projects at first which will bring me to manage a small team.

Experiences

Current Experience

  • Quality Operation Associate Zaventem, Belgium
    Since January 2014

    Restore and maintain the compliance of the drugs passing through Belgium. Ensure all of them are covered by an export/import Belgian licence by following the below actions:

     

    •Identification of products to be included in the Manufacturing Authorisation (form V419)

    •Grouping of identical products by comparison of qualitative and quantitative composition

    •Preparation and submission of applications for changes to the Manufacturing Authorisation, to the Belgian Authorities (export dossier for non EEA markets and dossier as a sub-contractor for EEA market)

    •Preparation, implementation and tracking of the submission Schedule

     

    Consultant with Hays Pharma

Past Experience

  • Clinical and Ancillary Supplies Services, Associate Brussels, Belgium
    January 2012 --- January 2014

    •Support of the Clinical and Ancillary supplies component of assigned studies

    •Support contact with study team during clinical and ancillary start-up activities

    •Support in label review and country translations according to set procedures for regional or simple global study

    •Work with project team to ensure the required documents and process related to supply management are obtained

    •Where appropriate provide support for information logistics and document exchange to ensure smooth clinical supply transportation arrangements are agreed and set-up

    •Support maintenance of project specific clinical & ancillary supply logistics

    •Interact with drug and ancillary supply distribution, IVRS/IRT and label translation vendors during the set up and maintenance of related logistics

  • PhD student Brussels, Belgium
    September 2011 --- September 2012

    Thesis title: Caracterization of the role of the Spa47 protein in the virulence of Shigella flexneri and identification of specifics inhibitors of its ATPase activity

     

    Biochemisty & cellular biology (western blotting, SDS-PAGE,...)

    Microbiology (bacterial transformation, manipulation in biosafety level 2,..)

    Molecular biology (PCR, Manipulation of plasmid vectors, electrophoresis gels,...)

     

    Writing of project and defense

    Analysis of scientific data

    Participation of scientific events

Personality

Self Assessment :
AdaptabilityAssertivenessAttention to detailCollaborationEfficiencyFlexibilityOrganizationReaction to stressWillingness to compromise

Knowledge

Self Assessment :
LaboratoryMicrobiologyMicrosoft ExcelMicrosoft OfficePowerPointQuality Assurance (QA)Regulatory affairsRegulatory submissionsWriting Study Procedures and SOPsBiological Drug DevelopmentClinical researchClinical trial managementData entryEnglishGMP

Skills and Expertise

Self Assessment :
Create SOPsAdministrative supportArchive study documentsAttend seminarsCommunicate with sponsorInteract with CROsLabeling compliance with local regulations

Education

  • Master in Biomedical Sciences from Université Libre de Bruxelles in 2011

Training and Certification

  • Excel in 2014 Training
  • ICH-GCP in 2011 Training
  • Felasa C in 2011 Certification

Work Preferences

  • Notice Period:
    6 weeks
  • Work From Home:
    Yes, 1 Days
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Braine-l'Alleud, Belgium

Others

Driving License
  • Yes