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Summary

Medical and pharmaceutical services in quality Management systems and regulatory affairs for Medical devices, biocides and pharma. Free Lance industrial pharmacist and Biomedical engineering Interested in projects guidance for medical device design, Technical file for CE application, risk management and process validation, Medical device Post marketing follow up.

Experiences

Current Experience

  • Manager
    Since January 2004
    Industrial Pharmacist and Owner of LVL Mediphar Consultancy in Medical devices QMS and regulatory affairs. Design in Medical devices and follow up. Responsible pharmacist for wholesaler's Consultancy in biocides applications QMS & GxP auditor (internal, external and third party) Process validation (EO sterilisation, irradiation sterilisation, clean room, packaging, ...)

Past Experience

  • RA
    January 2010 --- January 2014

  • Compliance Officer
    January 2013 --- January 2013

  • RP
    January 2013 --- January 2013

  • Free Lance Industrial Pharmacist
    March 1994 --- December 2004
    Implementation of QMS in Medical device sector; Implementation of GDP at different wholesaler's Regulatory affairs in Medical devices and Pharma responsible for pharmacovigilance and pharmaceutical information. File Maker pro Database developer

  • Industrial Pharmacist
    September 1990 --- August 1993
    Regulatory and GMP assistant

  • Pharmacist
    January 1989 --- September 1990
    GMP implementation New product and production implementation

Personality

Self Assessment :
Analytical thinkingCommunicativeCreative thinkingIndependenceProblem solving

Knowledge

LinkedIn Assessment :
Regulatory affairsMedical DevicesCE markingGMPQuality SystemsCAPAISO 14971ISO 13485Process ValidationQuality SystemValidationsPharmacovigilancemanagementClinical trialsBiotechnologySOPValidationPharmaceutical Industry

Skills and Expertise

Self Assessment :
Analytical skills Create SOPs Design case record forms Guide students Interpret data Search literature on clinical trials Write papers Write protocolsApprove Label Master SheetAseptic techniquesAssemble regulatory applicationsAssess adverse reactionsWrite clinical evaluation reportsValidate dataTrain on site staff

Education

  • Biomedical and clinical engineering in Biomedical science from RUG in 1997
  • Industrial pharmacist in Pharmaceutical science from RUG in 1988
  • Pharmacist in Pharamceutical science from RUG (University of Ghent - Belgium) in 1987

Training and Certification

  • GMP auditor conversion course Certification
  • ISO 9001 & 13485 lead auditor Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
French
Full Proficiency
English
Full Proficiency

Work Preferences

  • Locations I am interested in:
    Belgium France Netherlands
  • Work From Home:
    No
  • Work Regime:
    BrightOwl freelancer :    8 - 16 Hours per week
  • International:
    Yes

Area / Region

Landegem, Nevele, Belgium

Others

Driving License
  • Yes