微生物检测员

1.Generate all necessary test procedure, perform analysis of in-process sample, drug substance, drug product and stability study sample under cGMP standards.

撰写所有必须的检测规程，根据检测规程，依照相关cGMP标准对中间样品，原液，制剂和稳定性样品进行分析检测；

2.Perform routine testing such as endotoxin, bioburden and sterility, understand technical aspects of the job, best practices, and adhere to cGMP compliance.

执行内毒素，微生物限度和无菌的日常检测，理解工作的技术原理，***做法，并遵守cGMP合规性；

3.Generate method verification protocol under ICH/USP/EP/CP guidelines, and draft method verification report after the completion of experiment.

根据ICH/USP/EP/CP指南生成方法确认方案，实验执行完成后起草方法确认报告；

4.Execute method transfer/qualification/validation of endotoxin, bioburden and sterility.

执行内毒素，微生物限度和无菌的方法确认；

5.Perform moderate data analysis and trending, document work according to GMP and notify management.

进行适当的数据分析和趋势分析，根据GMP进行文件工作并通知管理人员；

6.Handle the quality event such as change control, deviation and CAPA related to the testing.

负责处理与检测相关的质量事件，例如变更，偏差和纠正和预防措施。

Qualification 任职资格

1.B.S./M.S. degree.

本科/硕士学历。

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经验，或研究生及一年以上工作经验。

3.Extensive experience in micro related knowledge and testing skills.

具有丰富的微生物相关背景知识和检测技能

4.Excellent verbal and written communication skills in English.

有良好的英语口语和写作能力。