EU-Quality Assurance Auditor

# EU-Quality Assurance Auditor in Austria at Celerion

**Date Posted:** 13/4/2023
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## Job Snapshot

* **Employee Type:**
Full-Time
* **Location:**
Austria
* **Job Type:**
QA - Quality Control
Pharmaceutical
Science
* **Experience:**
Not Specified
* **Date Posted:**
13/4/2023

## Job Description

The main function of the Quality Assurance Auditor is the assessment and assurance of study, project, and process compliance with protocols, Celerion Controlled Documents, and applicable regulations and guidelines through internal and external audits.

**Essential Functions**
* Plan, prepare, conduct- remotely and/or on site - report and follow up on audits from our annual audit programs (includes Investigator Site, Study, TMF, Systems and Vendors).
* Review study events, deviations, investigations, and change control documentation; and assess acceptability of the content and documentation.
* Detect Quality issues and serve as the QA partner for CAPAs.
* Maintain QA files and QA audit reports/responses.
* Interact with internal and external clients to discuss QA observations and study related issues; and maintain effective and professional working relationships within and across departments in relation to study projects.
* Participate in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes.
* Assist with the preparation for and hosting of client audits and/or regulatory inspections.

## Job Requirements

* **Knowledge/Skills/Education/Licenses:**
+ Bachelor's degree in science, IT, business, or similar
+ In-depth knowledge/experience in clinical development/clinical trial conduct (Phases I to III)
+ 2-5 years of GCP quality experience (preferred)
+ Working knowledge of applicable regulations and guidance documents (GCP/GLP/cGMP/GDP/eRecords/eSignatures) (EMA required and FDA preferred)
+ Excellent oral and written communication skills
+ Fluent business English language skills (verbal and written)
+ Ability to organize and manage multiple priorities in a changing environment
+ Good Time Management skills
+ Attention to detail, tactful and diplomatic
+ Computer literate
+ Willingness to travel within EU/UK (up to 25%)