To perform with minimum supervision one or a limited number of specific functions within QA, the specific QA function could be:
1. Review of batch records and approve product disposition.
2. Review/approve of QC test methods, protocols & reports.
3. Release of raw materials, components, in-process materials and finished products.
4. Review/approval of instrument validation reports.
5. Management for raw materials sampling, RM coding, and package components inspection.
6. Oversee the annual product review and the database of product attributes statistic.
7. Oversee and coordinate the system of deviation (IR/LIR), and CAPA system.
8. IPC sampling and production line clearance
9. Document management
10. Change control management
11. Stability program management
12. Calibration management
13. Complaint investigation, FAR and recall management
14. Cleaning validation and verification management
15. Supplier qualification, internal audits.
Others: Assign as requested by supervisor.