Job Responsibilities/岗位职责

1.Participate in the construction and maintenance of the R&D system, participate in the management of the R&D system. Assist the implementation of the R&D quality system.

参与研发体系的建设及维护；参与研发系统的管理；协助研发质量体系的实施；

2.Report any finding in R&D lab management to CTO weekly, and plan the improvement as needed.

每周向CTO汇报研发实验室管理工作中发现的问题，并提出整改措施；

3.Responsible for the management of the daily activities of R&D site, supervise the R&D site and its improvement, including on-site records, equipment management, daily maintenance, personnel operation, etc.

负责日常研制现场日常活动的管理，对研发现场进行督察并监督整改，包括现场记录、设备管理、日常维护、人员操作等；

4.Responsible for the distribution and review of R&D original records. Responsible for R&D experimental notebook standardization, Audit the completeness, authenticity of all the data, and write the audit records and reports. Review the timeliness, authenticity, completeness of auxiliary records.

负责研发原始记录的分发和审核管理；研发实验记录本规范性、完整性、数据真实性抽查，并形成记录和报告；辅助记录及时性、真实性、完整性抽查；

5.Responsible for the review process instruction, batch production records, quality standards, verification plans/reports, testing procedures, testing records/reports and other documents for R&D.

负责研发用工艺规程草案、部分批生产记录、质量标准、确认方案/报告、检验操作规程、检验记录/报告等文件的审核；

6.Responsible for R&D material management, including purchasing, requisitioning, inventory,etc.

负责研发物料管理，包括采购、领用、库存盘点等；

7.Training of R&D staff related to laboratory management.

对研发人员进行实验室管理相关的培训工作；

8.Complete other tasks arranged by superiors.

完成上级安排的其他工作。

Job Requirements/岗位要求

1.Bachelor degree, science subject is preferred.

本科学历，科学学科优先考虑；

2.1-5 years of lab management industry experience, pharmaceutical or medical device experience is preferred. Those with quality management experience in biopharmaceutical are better.

1-5年实验室管理行业经验，制药或医疗器械经验优先考虑。具备生物制药质量管理经验者更好；

3.Self-motivated, capable of handling independently, organizing and arranging multiple tasks, and able to perform under pressure and in line with the timeline.

有上进心，有能力独立处理，组织和善于安排多项任务，并能在压力下执行并符合时间线；

4.In-depth knowledge of GXPS and related guidelines and regulatory requirements.

熟悉GXPS和相关指南、法规要求；

5.Good oral and written communication skills in English and Mandarin, able to communicate effectively with other functional departments.

良好的英语和普通话口语和书写交流能力，能有效与其他职能部门沟通。