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Job Responsibilities 工作職責：
1. Generate all necessary test procedure, perform analysis of
in-process sample, drug substance, drug product and stability study sample
under cGMP standards.
撰寫所有必須的檢測規(guī)程，根據(jù)檢測規(guī)程，依照相關cGMP標準對中間樣品，原液，制劑和穩(wěn)定性樣品進行分析檢測；
2.Perform routine testing such as endotoxin, bioburden and
sterility, understand technical aspects of the job, best practices, and
adhere to cGMP compliance.
執(zhí)行內毒素，微生物限度和無菌的日常檢測，理解工作的技術原理，最佳做法，并遵守cGMP合規(guī)性；
3. Generate method verification protocol under ICH/USP/EP/CP
guidelines, and draft method verification report after the completion of
experiment.
根據(jù)ICH/USP/EP/CP指南生成方法確認方案，實驗執(zhí)行完成后起草方法確認報告；
4.Execute method transfer/qualification/validation of endotoxin,
bioburden and sterility.
執(zhí)行內毒素，微生物限度和無菌的方法確認；
5. Perform moderate data analysis and trending, document work
according to GMP and notify management.
進行適當?shù)臄?shù)據(jù)分析和趨勢分析，根據(jù)GMP進行文件工作并通知管理人員；
6.Handle the quality event such as change control, deviation and
CAPA related to the testing.
負責處理與檢測相關的質量事件，例如變更，偏差和糾正和預防措施。
Qualification 任職資格;
1.B.S./M.S. degree.
本科/碩士學歷。
2.Bachelor’s degree in a scientific discipline with 3+ years’ experience in quality control systems, or Master’s degree with 1+ years’ experience.
本科及三年以上工作經驗，或研究生及一年以上工作經驗。
3.Extensive experience in micro related knowledge and testing skills.
具有豐富的微生物相關背景知識和檢測技能。
4.Excellent verbal and written communication skills in English.
有良好的英語口語和寫作能力。