Quality auditor job description

Quality auditor job description

Quality auditor job description

Job purpose of Quality auditor is to assist all aspects of the internal quality systems audit program including audit planning, execution, follow-up and re-audit if necessary.

Key duties/responsibilities of Quality auditor:

1. Prepare training materials for different sections of the QSR, as required.
2. Provides internal communication regarding compliance issues and applicable regulation changes.
3. Aids in the creation of gap analysis to any new/changed regulations.
4. Work with the departments audited to resolve compliance issues, provide recommendation, communication on status of action resolution and bringing to management issues that require attention tracking corrective actions.
5. Maintain files generated from each audit.
6. Responsible for on-site audit of supplier quality systems.
7. Plan audit, execute and prepare audit report.
8. Maintain files generated from each audit.
9. Responsible for executing internal and external Good Clinical Practices audits.
10. Work with the auditee to resolve compliance issues, provide recommendation, communication on status of action resolution and bringing to management issues that require attention tracking corrective actions.
11. Maintain files generated from each audit.
12. Formally document findings.
13. Maintain files generated from each audit.
14. Perform necessary follow-up which include communicating with auditee(s) on status of action resolution.
15. Responsible for executing Good Laboratories Practices audits at External Laboratories that are performing non-clinical studies.
16. Work with the auditee to resolve compliance issues, provide recommendation, communication on status of action resolution and bringing to management issues that require attention tracking corrective actions.
17. Maintains up to the date the training program.
18. Responsible for execution of Internal audits.
19. Plan audit, execute and prepare audit report.
20. Formally document findings.

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