Job Responsibilities/工作职责

1. Participate in the implementation of environmental monitoring plan, including sampling, monitoring and trend analysis. Understand the post technical requirements and operation specifications to ensure cGMP compliance;

参与执行环境监测计划，包括取样、监测和趋势分析。理解岗位技术要求、操作规范，确保cGMP符合性；

2. Participate in the implementation of water system monitoring plan, including water system sampling and bio-burden testing, endotoxin testing and other physical and chemical analysis. Ensure cGMP compliance during implementation;

参与执行水系统监测计划，包括水系统的取样及微生物负载分析、内毒素分析及其它理化分析等。确保执行过程中cGMP符合性；

3. Participate in confirming whether the monitoring results of clean area, water system and gas are acceptable and distributing the results;

参与确认洁净区域、水系统及气体的监测结果是否可接受，以及结果分发；

4. Participate in drafting SOP and ensure the implementation of all relevant sops, and participate in training department members or other departments;

参与起草SOP并确保所有相关SOP执行，参与培训部门成员或其他部门；

5. Participate in other work arranged by superior leaders.

参与上级领导安排的其他工作。

Job Requirements/岗位要求

1. College degree and above in a pharmaceutical, chemical or biological discipline;

大专以上学历，药学、化学或生物学相关专业；

2. Strong background in standard and specialized methodologies for biologics products preferred;

具有较强的生物制品检测背景知识；

3. Thorough knowledge of GMP regulations and documentation, the basic statistics required in data analysis;

了解GMP法规和文件和基本数据分析统计学知识；

4. Preferably with excellent oral and written communication skills in Chinese and English (Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving investigations and theory, ability to write technical documents.

良好的英文和普通话口头和书面沟通能力 (听、写和说)，可以与其他职能部门和管理层沟通解决调查或理论问题，并具备撰写技术文件的能力。