Quality Assurance Auditor

Quality Assurance (QA) Auditor Good Manufacturing Practice (GMP)

Locations : Poland or Bulgaria

This role will involve 12 to 15 audits in Europe per year (Max of 30% of travels)

• Do you have a Bachelor- or Master Degree with a bio medical or life science background and work experience as a Good Manufacturing Practice auditor?

• Do you have excellent communication skills and do you see performing audits on our suppliers and processes as an exciting challenge? ICON is looking for a QA Auditor for their Early Development Services (EDS) and Distribution

The Early Development Services (EDS) division of ICON is a global leader in providing early-phase clinical research, bioanalytical services and manufacturing 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 where you will assume responsibility for quality assurance activities to support our Good Manufacturing Practice (GMP) Pharmacy and Quality Control (QC) Laboratory.

• Perform contracted, routine and complex internal self-Inspections and 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 delivering the supplier audits as assigned to you.

• You will be additionally responsible for facilitating client audits and regulatory inspections

• Work closely with our QPs/Pharmacists in our GMP manufacturing and distribution facilities.

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;

• Work experience in sterile manufacturing experience 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.

• Able to work office based from our office in Warsaw,.

• A self-starter with drive and enthusiasm.

• Appropriate professional qualification as a GMP Auditor/Lead Auditor.

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

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