# Clinical Audit Specialist

**Company**: IQVIA
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Madrid-Spain/Senior-QA-Auditor---GCP-Audits_R1555412?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_5f5e1914-b6a

## Description

We are seeking a Clinical Audit Specialist to plan and conduct independent clinical audits to assess compliance with regulations, guidelines, and operating procedures. You will prepare and distribute reports of findings to supervisor, operations staff, management, and customers, and provide consultation in interpretation of regulations, guidelines, policies, and procedures.

**Responsibilities**

- Plan, schedule, conduct, report, and close audit activities in various countries to assess compliance with applicable regulations, guidelines, customer requirements, IQVIA SOPs, and project-specific guidelines/instructions

- Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers

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

- Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA), and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits

- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements

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

- Lead/collaborate/support in QA initiatives/projects for quality, process improvements

- Assist in training of new Quality Assurance staff

- May be required to manage Quality Issues

- May present educational programs and provide guidance to operational staff on compliance procedures

- May perform pre-inspection visits at sites, host audits/inspections, and assist in regulatory facility inspections

**Requirements**

- Certified to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011

- 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits

- Experienced in the conduct of clinical trial Investigator site audits

- Experience in the conduct of clinical study report/data management clinical trial audits is preferred

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

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

- Knowledge of quality assurance processes and procedures

- Strong interpersonal skills

- Excellent problem-solving, risk analysis, and negotiation skills

- Strong training capabilities

- Effective organization, communication, and team orientation skills

- Ability to initiate assigned tasks and to work independently

- Ability to manage multiple projects

- Ability to establish and maintain effective working relationships with coworkers, managers, and clients

## Skills

### Required
- clinical audit
- regulatory compliance
- quality assurance
- pharmaceutical research
- risk analysis
- negotiation
- training
- communication
- team orientation

### Nice to have
- clinical study report/data management clinical trial audits

---

Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Madrid-Spain/Senior-QA-Auditor---GCP-Audits_R1555412?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)