Job Responsibilities/工作职责
1. Lead or participate in the implementation of environmental monitoring plan, including system implementation, plant confirmation and continuous monitoring (sampling, monitoring and trend analysis). Ensure the smooth progress of the monitoring work, and be responsible for the testing and monitoring results;
领导或参与环境监测计划实施，包括系统执行、厂房确认、持续监测（取样、监测和趋势分析）；保证监测工作顺利进行，并对各项检测及监测结果负责；
2. Lead or participate in the implementation of process water system monitoring and gas monitoring plan to ensure that process water and gas medium meet the quality standard requirements;
领导或参与工艺用水系统监测和气体监测计划实施，确保工艺用水和气体介质符合质量标准要求；
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 the implementation of environmental monitoring, water system monitoring and gas monitoring related changes; Participate in the investigation of abnormal events, OOS/OOT and deviation; Ensure that the above changes and investigation process comply with relevant laws and regulations;
参与实施环境监测、水系统监测和气体监测的相关变更；参与实施相关的异常事件、OOS/OOT、偏差相关调查工作；确保上述变更及调查过程符合相关法规要求；
5. 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；
6. 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. BS degree and above in a pharmaceutical, chemical or biological discipline;
本科以上学历，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。