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(資深)品管專員(Sr.) QC Specialist (微生物Microbiology)
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企業名
美時化學製藥股份有限公司
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工作地點
南投縣南投市
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薪資
月薪45000~0元
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工作內容
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.
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https://central1111.com.tw/turn/