Principal Auditor, Quality Assurance

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
 

Quality Assurance (QA) Auditor GMP – Poland or Bulgaria

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 an exciting challenge? ICON is looking for a QA Auditor for their Early Development Services (EDS) division in Groningen, the Netherlands.

The Early Development Services (EDS) division of ICON 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 quality assurance activities to support our Good Manufacturing Practice (GMP) Pharmacy

• Perform contracted, routine and complex internal audits according to client expectations and/or ICON SOPs. The exciting potential to function as a lead auditor on an audit team. Ensure planning, conduct, reporting, responses and follow up actions are managed according to ICON internal procedures.

• You will review and assess non-conformities and other pertinent GMP documentation as per recognized GMP standards of EMEA/FDA during your duties as a GMP Auditor.

• 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 ICON staff and client representatives.

• You will be additionally responsible for facilitating client audits and regulatory inspections at the aforementioned locations.

• Work closely with our QPs/Pharmacists in our GMP manufacturing facility in Groningen with the and the Head of QC in Assen on GMP Testing activities.

What do you bring as a Quality Assurance Auditor?

• Life science degree at Bachelor or Masters level from an accredited institution.

• Previous experience working as a GMP Auditor (at least 4-5 yrs).

• Work experience in early phase clinical trials or drug safety is considered an additional benefit.

• Fluency in English

• You are a self-motivated, focused individual with excellent communication skills. A strong personality who functions well either as a team member or sole contributor.

• Technically competent in all aspects of Auditing and GMP manufacture.

• Experience of facilitating/hosting audits and Inspections.

• Be based in Bulgaria or Poland, with an emphasis on office working at either one of these locations 3 days per week.

• A self-starter with drive and enthusiasm.

• Appropriate professional qualification as a GMP Auditor/Lead Auditor or membership of the IRCA.

Apply for the position:

If you are interested in a dynamic job and career, please send us your application letter and resume in English.

Benefits of Working in ICON:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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Are you a current ICON Employee? Please click here to apply: link