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[담당업무] 1. Document review
- Review SOP’s on handling of CTM (Clinical Trial Material) in accordance with local regulations, GSDP (Good
Supply and Distribution Practice) and principal requirements.
- Review or approve documents prepared by OP (Operation) and PM (Project Management) team.
- Review or approve facility related documents (validation/calibration/qualification etc.)
- Review Quality agreement with clients.
2. External audit
- Prepare the external audit in accordance with local regulations, GSDP and principal requirements.
- Gemba walk prior to audit
- Follow up CAPA for the finding delivered.
- Report audit results and audit schedule to RQA.
3. Supplier Management
- Conduct regular supplier audit and prepare audit report.
- Coordinate supplier audit schedule.
4. Training
- Conduct regular SOP training, GSDP training.
5. Deviation & Change control & Near miss
- Review deviation report, Nearmiss report and documents related change control. (e.g. CRF, Implementation
form, RA)
- Update status of deviation, Nearmiss and change control on tracker.
- Verify effectiveness of CAPA and change.
6. Quality KPI
- Report status of deviation, Nearmiss, change, external audit to RQA.
- Update status of deviation, Nearmiss, change, external audit for monthly management review
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