1) Responsible for releasing the products after importation in accordance with results of batch release test (Gov’t QC test for Biological products, Local QC test for Pharma products).
- Manage whole procedure related to batch release tests for every importation.
- Arrange reference standards, laboratory animals and product samples properly so that the tests are done on time.
- Support the QIA to set the QC standard newly or revise the standard.
2) Responsible for the quality procedure.
- Prepare internal and external audits for the local warehouse.
- Manage internal audits and submit the report to the QIA annually.
- Monitor and correct the products packaging corresponding with relevant laws and regulations.
- Report PQC and PVG to the regional office.
3) Support RA function
- Prepare and submit re-evaluation and re-assessment report