品質合規(資深)專員 Quality Compliance (Sr.) Specialist

1. Establish analytical methods of microbial and execute method validation to  

ensure analytical method accuracy. 

2. Issue blank test report for conduct raw material/package material, semi-  

product/product and stability analysis, sampling and records, to ensure product  

quality meets PIC/S GMP requirements. 

3. Review of project plans and analysis result reports, inspection/test reports, and  

SOPs. 

4. Conduct test on water for production, Total organic Carbon of water system in  

laboratory systems and microbial test to ensure the quality of the water. 

5. Conduct preparations of growth mediums and potency and growth tests of  

growth mediums to ensure microbial test run smoothly. 

6. Conduct bacterial sub-culturing ,culturing, identification and counts to ensure  

microbial tests run smoothly. 

7. Conduct environmental monitoring of production zones A,B and C(bacterial test  

on air conditioning system to ensure the conditions of production environment  

meets GMP requirements. 

8. Conduct cleaning and maintenance of all instruments and equipment,  

calibrations/validations and sort yearly assessment reports to maintain normal  

usage of instruments and equipment. 

9. Perform self-inspections or internal audits as required by the audit schedule.