PRAHS

  • QA (Quality Assurance) Auditor GLP

    Job Locations (All) | Netherlands
    Posted Date 1 month ago(12/10/2018 2:47 PM)
    ID
    2018-50825
  • Overview

    When you join PRA Health Sciences, you will not only witness the future of clinical development. You come to shape it!

    Do you have a Life Science Degree (Bachelor/Master) and are you interested in working in an international organisation? Do you see performing audits within a GLP environment as a challenge? PRA Health Sciences is looking for a Quality Assurance Auditor! 

    The Early Development Services (EDS) division of PRA is a global leader in providing early-phase clinical research (phase I and IIa) and bioanalytical services to the pharmaceutical and biotechnology industries. With a reputation built on excellence, quality and professionalism, we work with leading pharmaceutical and biotechnology companies, performing clinical research and bioanalytical trials on many of the most advanced experimental drugs and biologics in development today. Employees of EDS are enthusiastic and
    dedicated and work in a dynamic informal organization.

    Responsibilities


    What will you be doing as
     Quality Assurance Auditor?

    We are looking for you to join our team in Assen, the Netherlands where you will take responsibility for Bioanalytical Laboratory study audits and parts of the PRA audit program.

    • Perform routine and complex study, vendor and process audits according to GxP regulations, scientific guidelines, client expectations and/or PRA SOPs. May function as a lead auditor on an (international) audit team. Ensure planning, conduct, reporting, responses and FU actions are managed according to internal procedures
    • Further aspects of this challenging role include the interpretation of regulations and guidance documents governing Bioanalytical studies (GLP, GCP, EMA etc) and applying this within day-to-day structures for PRA staff and client representatives.
    • You will be additionally responsible for facilitating client audits and regulatory inspections at PRA.

    Qualifications

    What do we ask of you?

    • Life science degree (Bachelor or Master) from an accredited institution
    • Previous experience working as a GLP Auditor
    • Additional experience on any of the following topics is considered a pro: Dataintegrity, CSV
    • Work experience in a bioanalytical laboratory is considered an additional benefit
    • Fluency in English
    • You are a self-motivated, focused individual with excellent communication skills


    What can we offer you?

    A challenging position in our state-of-the-art Lab in Assen, the Netherlands.

    • We offer a competitive salary and an excellent working environment
    • PRA has its own collective labor agreement that provides good conditions for our employees like 35 holiday days per year and a good pension fund
    • Every year we organize (sporting) activities aimed at, among other things, teambuilding and conviviality. We also engage ourselves socially and, for example, we climb mountain peaks for a good cause
    • You start with a one-year contract with a view to permanent employment. The contract is for 32 or 40 hours per week


    Contact information:

    If you require further information please contact Chenthuran Raveerathan or Wytske Bijma, Staff Recruiting Consultants on +31 50 40 22 222.



    Apply for the position:

    If you are interested in a dynamic job and career, please send us your application letter and resume in English or Dutch. Applicants that are suitable will be invited for a cup of coffee as soon as possible!

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