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2017-40782

2017-40782

Title 
Quality Assurance Auditor GLP
Job Locations 
-
Netherlands
Netherlands-Groningen
Posted Date 
8/18/2017

More information about this job

Overview

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 45+ 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 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.

 

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

We are looking for an experienced Quality Assurance Auditor 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 audits according to regulations, 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
  • You will verify, identify and report non-conformities adhering to recognized standards of EU good manufacturing practice.
  • 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

To be successful in this exciting role you should have:

  • Life science degree (Bachelor or Master) towards life science
  • You have either previous experience working as a GLP Auditor (1-2 years min.) OR you have experience working in bioanalysis and you are motivated to move towards QA
  • Fluency in English, conversational in Dutch
  • You are a self-motivated, focused individual with excellent communication skills

      We offer you:

We offer a competitive salary and an excellent working environment in our state-of-the-art laboratory in Assen, the Netherlands. As this is an office based role, we welcome you to discover the beauty of the Northern part of our country. As we continue to expand, there will be career opportunities on a truly global scale.

 

How to apply:

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.

 

Contact information:

If you require further information please contact Rene van Wijk, Director HR or Wytske Bijma, staff recruiting consultant on +31 50 40 22 222.

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