Quality Assurance Auditor

Roles&Responsibilities-

1. To maintain copies of all approved study plans and their amendments (if any) and Standard Operating Procedures (SOPs) in use in test facility
2. To have access to an up to date copy of Master Schedule
3. To review the study plan/amendment/SOPs as per compliance with principles of GLP. This review is to be documented
4. Review of Deviations and Change controls in the test facility
5. Routine review of logbooks, environmental monitoring and power backup system.
6. To conduct inspections to verify that all studies are conducted according to GLP principles. This inspection also should verify that; SOPs and study plan are available with study personnel.
7. Preparation of schedule for test facility audit.
8. Three types of inspection are to be conducted viz.
9. Review of final report to confirm that methods, procedures and observations are accurately and completely described and the reported results reflect completely the raw data of the study. Accordingly, a statement is to be issued and to be delivered along with study report.
10. i) study based, ii) facility based and iii) process based. Records of all inspections are to be retained and archived.

Qualification-M.Sc. chemistry or relevant