Internal Auditor Quality Assurance jobs

Responsibilities

1. Planning and hosting of client audits and/or regulatory inspections of Novotech.
2. Perform audits of investigator sites, vendors, Trial Master Files, internal processes and systems.
3. Ensure that audit results are formally recorded and reported in a timely manner and that corrective / preventive actions are implemented effectively.
4. Participate in the investigation and evaluation of quality events, root cause analysis, CAPA plan and follow-up activities.
5. Evaluation of third-party vendors for clinical trial services.
6. Review and approval of GxP computerised system validation documents.
7. Ensure QA tracking systems are up to date
8. Provide GCP and QA advice and training
9. Develop and review written procedures and other documents for the Novotech QMS
10. Generate and provide metrics, status and trend reports and other information, as required by management.
11. Liaise with client, vendors and internal operational staff on quality aspects.
12. Maintain an up to date knowledge of appropriate national and international GCP legislation and guidelines that affect the business.