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Experiences

Current Experience

  • QA Officer - Anacura medical


    Since April 2017
    duties in this current position include e.g. qa document writing and control, complaint and non-conformity handling, capa review, conducting internal audits, qa Training for new employees, project work supporting continuous improvement; duties embedded within and in accordance to the Medical laboratory qms and ISO 15189 guideline for medical labs. Duties in this current position include e.g. QA document writing and control, complaint and non-conformity handling, CAPA review, conducting internal audits, QA training for new employees, project work supporting continuous improvement; duties embedded within and in accordance to the medical laboratory QMS and ISO 15189 guideline for medical labs.

Past Experience

  • CMC Technical Writer

    September 2016 --- March 2017
    key responsibilities in this position included the preparation, writing and Editing of technical Documentation relating to cmc and biopharmaceutical development activities in Compliance with regulatory guidelines.

  • Advisor clinical trials

    April 2013 --- August 2016
    key responsibilities in this position included drafting and Editing of regulatory Clinical Trial Documentation (ec and ca Applications, review of study contracts), funding Applications and providing advice and Training to principal investigators and study coordinators.

  • Scientific researcher (PhD)

    October 2009 --- March 2013
    key responsibilities in this position included cooperating in scientific field­- and Laboratory work, data collection and analyses within a eu­ project, Scientific writing and presenting Research.

  • Administrative help (student work)

    June 2006 --- January 2009
    during summer periods

Knowledge

LinkedIn Assessment :
Clinical researchRegulatory affairsScientific WritingGood Clinical Practice (GCP)Good Manufacturing Practice (GMP)Epidemiologial ResearchStatistics SPSSScalp Hair ResearchISO 15189Quality Management SystemsDocument ControlComplaint and non-conformity handlingICP-MSUPLC-MSMSCMC Technical writing

Skills and Expertise

Self Assessment :
Create SOPs Develop clinical trial protocols Interact with physicians Interact with nurses Report data Search literature on clinical trials Write papers Write protocolsAct as the main line of communication between the sponsor and the investigatorAdministrative supportAdverse event reportingApprove patient informationArchive documentationAssemble regulatory applicationsAssist study siteAttend seminars, courses and meetings within and outside the companyClinical data collectioncollaborate in research projects at universitiesCollaborate with principal investigatorCommunicate with sponsorConduct literature searchesContract approvalCoordinate with the ethics commiteeCreate study documentsDocument data collection systemdrafting grant applicationsEnsure good clinical practice (GCP)Follow-up of external auditsFollow-up of internal auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesInformed consent processLate-stage regulatory filing (MAA, BLA)Maintain Quality Management System (QMS)Manuscript preparation and reviewOrganise meetingsPrepare internal auditsRegulatory documentationStatistical analysisTrain Staff

Education

  • Doctor in Biomedical Sciences in from Ghent University in 2013
  • in from Karl Franzens University of Graz in 2009
  • Master Biomedical Sciences in from Ghent University in 2009
  • Latijn-Wetenschappen in from Sint-Bernarduscollege in 2004

Training and Certification

  • GMP in 2017 Training
  • ISO 15189 in 2017 Training
  • Academic writing in 2013 Training
  • GCP in 2016 Certification
  • Coordinator Clinical Studies in 2013 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Professional Proficiency
French
Elementary Proficiency
Swedish
Elementary Proficiency

Work Preferences

  • Notice Period:
    3 weeks
  • Locations I am interested in:
    Borås, Sweden Gothenburg, Sweden
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    min. 50% FTE
    BrightOwl employee :    min. 50% FTE
  • International:
    Yes

Area / Region

Belgium

Others

Driving License
  • Yes

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