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Experiences

Current Experience

  • QA Officer
    Since October 2014

    Primary QA contact person for the Supply Chain Management department (Manufacturing, QC and Logistics)

    Main responsibilities include:

    • Batch record review for drug substance, drug product and packaged product. Prepare release documentation for the Qualified Person.
    • Prepare, review and approve Deviations, Changes and CAPAs.
    • Review of quality documents e.g. validation, stability, technical and transfer protocols and reports.
    • Review SOPs and Work instructions and related forms.
    • Perform both internal and external Audits. (GMP, GLP, GDP, CMO's and Suppliers) -
    • Prepare and participate in regulatory audits (IGZ and FDA)

Past Experience

  • Senior Research Technician
    January 2013 --- September 2014

    • Process development for off-the-shelf dendritic cell based vaccines.
    • Involved in the Up scaling of dendritic cell cultures in cellbags using the Biowave 2/10 system.
    • Assay development for phenotypic and functional characteristics of the product using FACS, MLR Migration and T-cell assays.
    • QA support: reviewing, filing and archiving of QA documents.

  • Labcoordinator Analytical Development
    January 2012 --- December 2012

    • Construction and organization of new ML-II analytical development labs. (750M2)
    • Responsible for the organization, quality and safety of these labs.
    • Main tasks: planning, purchase of equipment, set up of the lab organization rules for safety and quality on the labs, set up and maintain documentation systems, training of new employees, host internal and external audits.

  • Technician Analytical Development
    May 2007 --- December 2011

    • Development and qualification of (cell based) assays for testing of quantity, potency, purity and identity of vaccines against infectious diseases.
    • Used techniques: (Q)PCR, ELISA, Westernblot, infectivity assays, DNA isolation and purification, Gel analysis, Cell culture (suspension and adhesive) working with viruses (adeno, Influenza, Polio)

  • Analist molecular biology
    June 2006 --- August 2006
    Following my internship I continued the research for another 3 months and worked on - Hit finding and hit optimization. - Development of assays to be used for screening of new drug components.

  • Trainee molecular biology
    November 2005 --- June 2006
    Mutation studie on a G-protein coupled receptor. Worked on the development of new constructs that contained mutations of the target protein. These mutants were tested in different assays for expression, binding and potency to see the effect of this mutation on the protein. This information was used for better understanding receptor- ligand interaction and for the development of new and improved drug compounds.

  • Trainee
    February 2005 --- June 2005
    Research on Genes involved in restenosis and cardiac diseases.

Personality

Self Assessment :
Analytical thinkingAttention to detailCollaborationCommunicativeCoordinationFlexibilityIndependenceOrganizationResponsibilityResult Oriented

Knowledge

Self Assessment :
Good Manufacturing Practice (GMP)Good Laboratory Practice (GLP)Good Distribution Practice (GDP)Quality Assurance (QA)Quality ManagementAuditingCAPAChange ControlQA complianceFailure Mode and Effect Analysis (FMEA)Risk AssessmentStandard Operating Procedure (SOP)Life SciencesBiotechnologyLaboratory ManagementManufacturingMolecular & Cellular BiologyCell Based AssaysAssay developmentTroubleshooting LabtechnicianQuality AuditingChange ManagementGMPVaccines
LinkedIn Assessment :
ELISAAssay developmentmolecular biologyCell CultureBiotechnologyqPCRBiopharmaceuticalslaboratory organisationVaccinesLife SciencesLifesciencesTroubleshootingTrendingWestern BlottingMolecular CloningDNA extractionElectrophoresisInfectious diseasesVirologyMLRMigrationBiowaveFACS analysisGMPQuality AssuranceDocument Review

Education

  • pre-master in Life Science, Medical Biology from Radboud Universiteit Nijmegen in 2007
  • BSc in Life Science, Molecular Biology from Hogeschool van Utrecht in 2006

Training and Certification

  • Data Management for Clinical Research Certification
  • Tropical diseases and development help in third world countries Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Professional Proficiency

Area / Region

Leiden, Netherlands

Others

Driving License
  • No