Job Description

This well recognised CRO is recruiting within its Quality department & has an opportunity for a Clinical Quality Assurance (CQA) Auditor who will primarily be responsible for the continued maintenance of a CQA System to ensure trials contracted to the company are conducted & the data is in compliance with applicable regulatory requirements.

As part of the CQA Department, the auditor is responsible for, but not limited to:
• Providing guidance to operations in their documentation & application of procedures
• Supporting company units & their quality control systems
• Conducting periodic audits
• Providing consultancy on quality & regulatory related issues

Key responsibilities include:
• Hosting sponsor audits & regulatory authority inspections at Company locations
• Responding to sponsor audits
• Resolving issues with sponsor
• Conducting audits
• Reviewing company SOPs for compliance
• Providing technical support
• Managing CQA projects & departmental SOPs

Qualifications/Skills Required

- Degree level educated in health sciences
- 4 years relevant clinical development experience
- Strong organisational skills
- Attention to detail
- Excellent communication and interpersonal skills
- IT literacy