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Experiences

Current Experience

  • MD Vigilance Expert – Pharmacist – Complaint & Vigilance Manager

    Haasrode, Belgium
    Since April 2010

    a Pharmacist with more than 13 years experience in the Quality Assurance, Regulatory Affairs  & cGMP requirements within the Pharmaceutical and Medical Device industry. since 2008, i joined terumo europe where roles of increasing responsibility have been held in maintaining quality, Risk Management and Clinical evidence systems. in my current position, i’m fully responsible for global complaint handling and vigilance system. i’m also a lead Auditor for Medical Device Quality System regulations.

    A pharmacist with more than 13 years experience in the quality assurance, regulatory affairs  & cGMP requirements within the pharmaceutical and medical device industry. Since 2008, I joined Terumo Europe where roles of increasing responsibility have been held in maintaining quality, risk management and clinical evidence systems. In my current position, I’m fully responsible for global complaint handling and vigilance system. I’m also a lead auditor for medical device quality system regulations.

Past Experience

  • Document Analyst – Responsible Clinical Evidence Haasrode, Belgium

    February 2008 --- April 2010

    tasks as Documentation Analyst:

     tasks as responsible Clinical evidence:

  • Junior qualified person & validation coordinator Hamont-Achel, Belgium

    March 2005 --- February 2008

    tasks as junior Qualified Person:

     tasks as validation Coordinator

    • responsible for the creation and execution of all SOP’s & validation protocols including: validation master plan (vmp), user requirement specifications (urs), design qualifications(dq), risk & impact analysis (ria), installation qualifications (iq), operational qualifications (oq), performance qualifications (pq) for the equipments and utilities, retrospective validation, analytical test method validation, Cleaning Validation and Computer System Validation.
    • responsible for the environmental monitoring system and all monitoring activities.

Personality

Self Assessment :
Analytical thinkingAdaptabilityCollaborationEfficiencyFlexibilityProblem solving

Knowledge

Self Assessment :
Pharmaceutical Industry Medical devices

Skills and Expertise

Self Assessment :
Analytical skillsInteract with regulatory stakeholdersConduct post-marketing surveillance studyDesign post-marketing surveillance studyEvaluate post-marketing surveillance studyDevelop training materials

Education

  • Master in Pharmaceutical Sciences from Alexandria University in 1998

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency
Dutch
Professional Proficiency
Arabic
Native

Work Preferences

  • Work From Home:
    Yes, 0 to 2 days per week
  • International:
    Yes

Area / Region

Heppen, Leopoldsburg, Belgium

Others

Driving License
  • No

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