PRAHS

  • Quality Assurance Auditor with focus on GMP in Groningen, the Netherlands

    Job Locations (All) | Netherlands | Netherlands-Groningen
    Posted Date 1 month ago(12/6/2018 4:02 PM)
    ID
    2018-50436
  • Overview

    Do you have a Bachelor- or Master Degree with a bio medical- or life science background and work experience as a GMP auditor? Do you have excellent communication skills and do you see performing audits on our clinical trials and processes as a challenge? PRA Health Sciences is looking for a QA Auditor for their Early Development Services division in Groningen, the Netherlands.

     

    The Early Development Services (EDS) division of PRA is a global leader in providing early-phase clinical research 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 Griningen, in the Netherlands, where you will assume responsibility for internal and contracted Good Clinical Practice (GMP) audits.

     

    You will:

    • Perform contracted, routine and complex internal audits according to client expectations and/or PRA SOPs. May function as a lead auditor on an audit team. Ensure planning, conduct, reporting, responses and follow up actions are managed according to internal procedures
    • You will verify, identify and report non-conformities adhering to recognized standards of EU good clinical practice
    • Further aspects of this challenging role include the interpretation of regulations and guidance documents governing GMP 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 you bring as Quality Assurance Auditor?

     

    As a person you are a self-motivated, focused individual with excellent communication skills.

     

    Next to that you have:

    • Life science degree on Bachelor or Master level from an accredited institution
    • Previous experience working as a GMP Auditor
    • Work experience in early phase clinical trials or drug safety is considered an additional benefit
    • Fluency in English, conversational in Dutch
    • Able to work office based from our site in Groningen, in the beautiful northern part of the Netherlands

     

    We offer you:

    • We offer a competitive salary and an excellent working environment close to our state- of-the-art clinic and GMP pharmacy in Groningen. As we continue to expand, there will be career opportunities on a truly global scale. If needed, we can support you with relocation.
    • 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, 36 or 40 hours per week

    Contact information:

    If you require further information please contact Wytske Bijma, staff recruiting consultant on  +31 50 402 22 22.

     

    Apply for the position:

    If you are interested in a dynamic job and career, please send us your application letter and resume in English. You can upload one document when you apply through our company website.

     

    PRA Health Sciences

    As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 70+ such drugs.

    At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace. 

    At PRA, borders do not create boundaries.  PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals.  Our growing workforce is comprised of over 15,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.


    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.



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