About this role
Role Overview
- Independently lead, plan, schedule, perform, and report a range of technology audits across all phases of Clinical Research
- Perform and deliver high quality audits / audit reports within specified timelines / budgets, independently or with limited oversight
- Travel internationally for audits, as required
- Collect and review responses to audit findings and follow-up / escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained and formally recorded
- Act as point of consultancy for Operations and Quality with regards to the implementation of adequate CAPAs with effective and timely escalation of relevant Quality Events where required
- Coordinate internal global process / system audits across regions and develop all necessary tools such as report templates, checklists and standard emails
- Ensure required audits are performed and reported in accordance with Parexel QA requirements, and on time
- Review audit reports, responses and other program deliverable to ensure consistent high quality
Requirements
- At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety / pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management
- Minimum of 2 years' experience in quality assurance, auditing, including sound experience of applicable GxP technology auditing
- Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research
Benefits
- Flexible work arrangements
- Professional development opportunities