岗位职责如下：

1. Manage and sample starting material , packaging material, semi-product and finished product. Evaluate the quality risk for abnormal issues.
从事原辅料、包材、中间产品、成品的取样管理，并对异常情况进行质量评价
2. To sample the clean media such as PW, WFI,PS. Identify the using point risk.  洁净介质如PW、WFI、PS的取样及日常测试。
3.Complete daily environmental monitoring of the clean room in the production department (monthly monitoring, annual monitoring,compressed air and nitrogen etc.),monitor the testing result, identify and evaluate the abnormal data. 
完成生产部洁净室日常的环境监测（月度监测、年度监测、压缩空气和氮气等）,监控测试数据，识别并评估异常数据；

4.To inspect the storage and manufacture process of  products on line. Identify any GMP incompliance during 0n-line QA inspection and follow the actions. 
对产品储存、生产过程进行在线检查，在日常检查中识别GMP不符合项并有效跟踪；
5.Pest Control  虫害管理；

6.Maintain the  in process control documents . 
过程控制文件系统的维护；
7.Support deviation/CAPA/Change control/FI/OOS handling.  协助偏差/CAPA/变更/失败调查/OOS的调查；
8.Environment data and clean medium data evaluation and alarm, as well as evaluation report preparation.
定期对环境监测数据及洁净介质监测数据进行评价，以及准备相关评估报告。

9.Complete the return inspection;

完成退货检查；
10.Management of nonconforming products

不合格品管理；

11.To finish other task that the supervisor assigned.
完成主管分配的其它任务。

任职要求：

1.College degree or above

专科及以上学历
chemical/pharmaceutical relevant 化学/药学相关专业
2.English reading, writing and speaking 
良好的英语听、说、读、写能力
3.Well knowing Microsoft Office

熟练使用计算机办公软件

4.Good communicate skills and team work awareness
良好的沟通技能及团队合作意识
5.Experience with GMP 
GMP相关经验及知识