Quality Assurance Auditor

Quality Assurance Auditor

Locations possible : Sofia (Bulgaria) and Warsaw (Poland)

Computer System Validation is mandatory for this role

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Here at ICON we are looking for a candidate with Computer System Validation and Auditing experience to join our Quality & Compliance team as a QA Auditor. This role is focused on conducting agile and risk-focused snapshot audits and assessments of projects, processes and departments. The ideal candidate will be able to provide value-added information in a timely manner, enabling the business to understand and mitigate quality and regulatory risks.

You will perform tasks relevant to the assigned Technical Quality & Compliance (Q&C) function including but not limited to conducting internal and vendor audits, computerized system validation reviews, supporting Sponsor Audits and Regulatory Authority inspections. 

What you need?

- Experience conducting GxP audits: Audit Lead responsibilities (planning, conducting, reporting) for Vendor/Supplier Audits

- Computer System Validation experience : Conducting Internal/Vendor Audits with a focus on Computerized System Validation

- Computerized System Validation (Documentation) Reviews: Experience performing a full review of documents within given SDLC (Val Plan, requirements, test cases etc).

In this role, you will be working with teams based in the US, India, EU, so a flexibility with working hours may be required.

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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