Job Responsibilities 工作职责
1. Write product quality standards, stability study protocol/report, standard preparation/qualification protocol, and stability protocol/report.
撰写产品质量标准、稳定性研究方案/报告、标准品制备/标定方案及稳定性方案/报告；
2. Responsible for conducting deviation investigations and change control related to the project
负责项目相关的偏差调查、变更；
3. Participate in the drafting and review of project contracts.
参与项目合同的起草、审核；
4. Break down departmental work according to the signed contract, allocate work tasks internally, track task progress, and deliver project data.
按照签署的合同分解部门工作，内部分配工作任务，追踪任务进度、交付项目资料；
5. Maintain good communication with other departments, timely obtain project updates, coordinate internal work arrangements, and promote timely project delivery.
与其他部门保持良好的沟通，及时获取项目近况，协调内部工作安排，促进项目按时交付。
Qualification 任职资格
1. Bachelor’s degree in a scientific discipline with 2+ years’ experience in quality control systems.
本科及2年以上工作经验；
2. Have a comprehensive understanding of GMP regulations and documents, and be able to independently handle deviations and change control.
全面了解GMP法规和文件，能独立处理偏差及变更;
3. Having experience in GMP laboratory, familiar with regulatory management requirements for stability and standard products.
有GMP实验室工作经验，熟知稳定性及标准品的法规管理要求;
4. Having excellent English speaking and written communication skills, and communicate with foreign clients without barriers.
有出色的英语口语和书面沟通技能，与国外客户无障碍交流;
5. Strong understanding ability and sense of responsibility, able to decompose, allocate, track, and deliver project tasks.
有较强的理解能力及责任心，对项目任务进行分解、分配、追踪、交付;
6. Having good communication, summarization, and expression skills, coordinate internal and other departments, and smoothly promote projects.
有较好的沟通、总结、表达能力，协调内部及其他部门，顺利推进项目。