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Quality Assurance Auditor GCP
Vacature Quality Assurance Auditor GCP
Quality Assurance (QA) Auditor GCP – Groningen, the Netherlands
Help to develop new drugs to optimize the life of patients. That is the mission of PRA Health Sciences! Contribute to our goal by making sure all our research meet the rules and guidelines of GCP.
How? As a Quality Assurance Auditor GCP.
Where? You will be working 1 or 2 days a week at our state-of-the-art clinic in Groningen, so it is necessary you live in the area or in the Netherlands.
What do you need? A Bachelor- or Master Degree with a bio medical- or life science background, work experience as a GCP auditor and excellent communication skills
Do you see performing audits on our 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.
What will you be doing as Quality Assurance Auditor?
We are looking for you to join our team in the Netherlands where you will assume responsibility for internal and contracted Good Clinical Practice (GCP) audits.
- 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 GCP 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
What do you bring as Quality Assurance Auditor?
- Life science degree on Bachelor or Master level from an accredited institution
- Previous experience working as a GCP Auditor
- Work experience in early phase clinical trials or drug safety is considered an additional benefit
- Fluency in English, conversational in Dutch
- You are a self-motivated, focused individual with excellent communication skills
- We expect you to be able to be in the office in Groningen at least 1 or 2 days a week, and for more days if circumstances require
We offer you:
- We offer a competitive salary and an excellent working environment in our state- of-the-art clinic 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 or 40 hours per week
If you require further information please contact Wytske Bijma, staff recruiting consultant on firstname.lastname@example.org or +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 via the Apply-Button.
PRA Health SciencesAs 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.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
Keywords: Vacancy, full-time, Groningen, Audit, QA.
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