# Clinical Auditor

**Company**: IQVIA
**Location**: Warsaw, Poland
**Experience**: senior
**Job type**: full-time
**Salary**: zł 168,100.00 - zł 312,100.00
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Warsaw-Poland/Poland--Senior-QA-Auditor---GCP-Audits_R1579143?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/clinical-auditor-17c4ce07-923/

## Description

We are seeking a Clinical Auditor to plan and conduct independent clinical audits to assess compliance with regulations, guidelines, and operating procedures.

The successful candidate will be responsible for:

- Planning, scheduling, conducting, reporting, and closing audit activities in various countries involved with IQVIA contracts

- Evaluating audit findings and preparing reports for operations staff, management, and customers

- Providing interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures

- Reviewing and approving investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA), and Effectiveness Check (EC) plans

- Evaluating policies and procedures for compliance with applicable regulations and guidelines

- Maintaining the electronic quality management system (eQMS) and providing support in relation to the audit lifecycle

- Leading and collaborating on QA initiatives and projects for quality and process improvements

- Assisting in the training of new Quality Assurance staff

- Managing Quality Issues, presenting educational programs, and providing guidance to operational staff on compliance procedures

The ideal candidate will have:

- 5 years of experience in a GCP environment, with 3 years in Quality Assurance Site Audit

- Experience leading clinical trial Investigator site audits (at least 7-10 per year)

- Certification to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011 (desirable)

- Knowledge of word-processing, spreadsheet, and database applications

- Extensive knowledge of pharmaceutical research and development processes and regulatory environments

- Strong interpersonal, problem-solving, risk analysis, and negotiation skills

- Effective organization, communication, and team orientation skills

- Ability to initiate assigned tasks and work independently

- Ability to manage multiple projects

The potential base pay range for this role is zł 168,100.00 - zł 312,100.00 per year.

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## Skills

### Required
- GCP
- Quality Assurance
- clinical trials
- regulatory compliance
- audit planning
- report writing
- consultation
- interpretation of regulations
- policies and procedures
- Root Cause Analysis
- Corrective Action Prevention
- Effectiveness Check

### Nice to have
- certification to conduct audits in Italy
- Italian

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Warsaw-Poland/Poland--Senior-QA-Auditor---GCP-Audits_R1579143?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)