JUMP TO CONTENT

Quality Assurance Auditor II - GMP

  1. Sofia, Warsaw, Johannesburg, Gdansk
JR133134
  1. Quality Assurance
  2. ICON Full Service & Corporate Support
  3. Office or Home

About the role

Quality Assurance Auditor II - Remote - Poland, Bulgaria or South Africa

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What will you be doing as Quality Assurance Auditor II?

We are looking for you to join our team in the Poland or Bulgaria where you will assume responsibility for quality assurance activities to support our Good Manufacturing Practice (GMP) Pharmacy audits.


•    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 within ICON or sub-contracted sites.

What do you bring as a Quality Assurance Auditor?


•    Life science degree at Bachelor or Masters level from an accredited institution.
•    2+ years of previous experience working as a GMP Auditor.
•    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.
•    A self-starter with drive and enthusiasm.
Travel: up to 45% of the time (approximately 1-2 travels per month to a vendor facility site).

#LI-Remote

#LI-MK2

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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

List #1

Day in the life

A picture of chemists on a superimposed periodic table
5 reasons why you should consider a career in Clinical Research

Teaser label

Inside ICON

Content type

Blogs

Publish date

01/17/2025

Summary

Five Reasons Why You Should Work at a Contract Research Organization Contract research organisations (CROs) play a pivotal role in advancing medical science, offering career opportunities that are

Teaser label

If you’re seeking a rewarding and fulfilling work environment, a career at a CRO might be the perfect fit.

Read more
Man with headphones on looking at a laptop
Tips to make a lasting impression in a video interview

Teaser label

Career Progression

Content type

Blogs

Publish date

05/10/2024

Summary

Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv

Teaser label

Ace your virtual job interview with these proven video interview tips.

Read more
Salary: Let’s talk about it.

Teaser label

Career Progression

Content type

Blogs

Publish date

12/21/2022

Summary

Salary expectations used to be something discussed after an interview process but now it’s something most recruiters typically ask within the first conversation. This is to ascertain if the remune

Teaser label

Things to consider heading into 2023 if you're thinking about moving jobs.

Read more
View all

Similar jobs at ICON

Workday TA Transformation Analyst

Salary

Location

Bulgaria, Sofia

Department

Full Service - Corporate Support

Location

Sofia

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Human Resources

Quality Assurance

Job Type

Permanent

Description

We are currently seeking a Senior HR Transformation Analyst to join our diverse and dynamic team. As a Senior HR Transformation Analyst at ICON, you will be pivotal in driving HR transformation initia

Reference

JR132974

Expiry date

01/01/0001

Maya Katsarska Read more Shortlist Save this role
Senior Quality Assurance Specialist

Salary

Location

Spain, Barcelona

Department

Language Services

Location

Prague

Warsaw

Barcelona

Reading

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Quality Assurance

Job Type

Permanent

Description

We are currently seeking a Senior Quality Assurance Specialist to join our dynamic team. You will play a critical role in ensuring and advancing quality across ICON’s Language Services department. Rep

Reference

JR132675

Expiry date

01/01/0001

Rowena Deswert Read more Shortlist Save this role
Quality Assurance Auditor II

Salary

Location

US, Salt Lake City (PRA)

Department

Full Service - Quality Assurance

Location

Salt Lake City

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Quality Assurance

Job Type

Permanent

Description

We are currently seeking a Quality Assurance Auditor II to join our diverse and dynamic team in our Early Phase Unit. As a Quality Assurance Auditor II at ICON, you will play a pivotal role in ensurin

Reference

JR132163

Expiry date

01/01/0001

Muna Nelke

Author

Muna Nelke
Muna Nelke

Author

Muna Nelke
Read more Shortlist Save this role
Senior HR Transformation Analyst

Salary

Location

India, Chennai

Department

Full Service - Corporate Support

Location

Bangalore

Chennai

Trivandrum

Bengaluru

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Human Resources

Quality Assurance

Job Type

Permanent

Description

We are currently seeking a Senior HR Transformation Analyst to join our diverse and dynamic team. As a Senior HR Transformation Analyst at ICON, you will be pivotal in driving HR transformation initia

Reference

JR132092

Expiry date

01/01/0001

Maya Katsarska Read more Shortlist Save this role
Senior QA Auditor - Client Audit Management

Salary

Location

Bulgaria, Sofia

Department

Full Service - Quality Assurance

Location

Sofia

Warsaw

Johannesburg

Tbilisi

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Quality Assurance

Job Type

Permanent

Description

The opportunity: The Audit Defense team are seeking an individual to join them as a Senior QA Auditor position.  This is a great opportunity for someone with a clinical background to develop their car

Reference

JR131582

Expiry date

01/01/0001

Maya Katsarska Read more Shortlist Save this role
Senior Auditor – Laboratory/GCP

Salary

Location

Ireland, Dublin

Department

Full Service - Quality Assurance

Location

Dublin

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Quality Assurance

Job Type

Permanent

Description

Location: Dublin, IE, working within our Clinical Laboratory environmentDue the business function alignment of this role, there is a requirement for the individual to be onsite at the Laboratory 3 out

Reference

JR130328

Expiry date

01/01/0001

Maya Katsarska Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above