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Experiences

Current Experience

  • PV and QA associate


    Since August 2014
    set up and maintain Quality System: gdp, GMP admin batch release complaints handling (quality problems, Adverse Events) capa management in trackwise internal audits preparation and follow up regulatory inspections Set up and maintain quality system: GDP, GMP Admin batch release Complaints handling (quality problems, adverse events) CAPA management in trackwise Internal audits Preparation and follow up regulatory inspections

Past Experience

  • Process Improvement Manager at GSK

    May 2011 --- July 2014
    o implement an electronic trial master file o Change Management o organize + give Training sessions o gap Analysis + optimize processes o connect with different departments, stakeholders o assessment of central study files for 2 large Phase III studies running in about 35 countries + ensure inspection readiness o set-up and follow up of action plan with study teams (internal + regional) to reach Compliance to gsk Documentation requirements

  • QA manager + Clinical trial pharmacist Phase 1/2 clinical research unit

    November 2006 --- May 2011
    o perform internal audits, participate in client audits and inspections of Health authorities o follow up on capa (corrective and preventive actions) related to gcp (Good Clinical Practice) o give gcp Training to Research unit team o review and approval of internal procedures + interaction with different stakeholders o liaise with belgian Health authorities on gcp/GMP regulations. o distribution, stock and preparation of investigational medicinal products o Coaching of a team of Pharmacists and Pharmacy assistants

Knowledge

LinkedIn Assessment :
Clinical trialsQuality Assurance (QA)GCPSOPGMPPharmaceutical IndustryCAPARegulatory affairsClinical DevelopmentCROICH-GCPRegulatory submissionsBiotechnologyClinical research

Education

  • Master's degree in Industrial Pharmacy from Katholieke Universiteit Leuven in 2010
  • Master's degree in Pharmacist from Katholieke Universiteit Leuven in 2004
  • in Latin - sciences from College Vita et Pax Schoten in 1998

Area / Region

Antwerpen, België

Others

Driving License
  • No

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