华信永益（北京）信息技术有限公司新闻资讯

Job Description Summary

The Chem Analyst will be responsible for performing and reporting of routine analytical tests in the Laboratory according to the specifications; drafting / revising / reviewing SOPs, methods, specifications, training models and IQ/OQ protocol; translating methods.

化学分析员的职责是根据质量标准负责操作及报告实验室的常规分析测试； 起草/修改/审阅标准操作规程 (SOP)﹑方法﹑质量标准﹑培训模块和IQ/OQ方案；翻译方法。

Job Description

PRIMARY FUNCTIONS主要职责

Participate in new, corporate and local projects and take part in the validation work throughout the plant, in which resources are required.

参与本工厂有资源需求的新的集团和本地的项目和验证工作。

Participate in the sampling and testing of utilities/raw materials, in-process samples, semi-finished/finished products.

参与公用工程， 原料，中间控制样品，半成品/成品的取样和测试。

Participate in the import analysis application in Shanghai Institute of Food and Drug Control (SIFDC) of all import drugs including API and semi-finished/finished products in compliance with Chinese Regulatory Requirement; contact SIFDC for analysis issues.

按照中国法规的规定参与包括活性药物物质和半成品/成品的进口药物在上海市食品药品检验所的报验工作，负责与上海市食品药品检验所联络检测事宜。

To be responsible for retain sample and stability sample management.

负责留样和稳定性样品的管理。

Ensure that all the raw data during the testing are correctly recorded down.

确保正确记录所有原始测试数据。

QUALIFICATION/EXPERIENCE资历/经验

Relevant Science College Diploma or Degree is essential.

相关的理工科大专毕业或相当学历。

Experience from pharmaceutical quality control laboratories and basic knowledge of GMP is desirable.

具备制药企业质量控制实验室经验和GMP知识。

Knowledge of HPLC, GC, NIR, UV, TOC and titrator system is desirable.

具备HPLC, GC, NIR, UV, TOC 和滴定仪的相关知识。

Knowledge of MS office software is required.

了解MS办公软件。

Basic English knowledge is required.

具备英语技能。