Quality Assurance Auditor II - GMP

Quality Assurance Auditor II - Office-/Home-based - Bulgaria or Poland

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).
 

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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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