Quality Assurance（QA）
Post duties：
1、药学、化学、生物等相关专业本科学历。
Bachelor degree in pharmacy, chemistry, biology and other related majors.
2、熟悉GLP规范，有一年GLP工作经验者优先；
Familiar with GLP specification. One year GLP working experience is preferred.
3、工作严谨、认真负责、原则性强、沟通能力强，具备良好的职业道德和团队意识；
Strict, conscientious, responsible, principled, strong communication skills, with good professional ethics and team spirit;
4、英语四级以上，能够看懂行业相关英语版指导原则、GLP规范。
English level four or above, can understand the industry related English version of the guiding principles, GLP specification.
Tenure requirements：
1、 全面负责质量保证部门的工作安排和运行；
Be responsible for the work arrangement and operation of the quality assurance department.
2、 按相应SOP要求，负责相应仪器设备及计算机系统验证的检查；
In accordance with the corresponding SOP requirements, responsible for the corresponding equipment and computer system validation inspection;
3、 按相应SOP要求，负责相应实验方案的检查；
According to the corresponding SOP requirements, responsible for the corresponding test plan inspection;
4、按相应SOP要求，负责相应分析方法的检查；
According to the corresponding SOP requirements, responsible for the corresponding analysis method inspection;
5、按相应SOP要求，负责相应实验过程的检查；
According to the corresponding SOP requirements, responsible for the corresponding test process inspection;
6、按相应SOP要求，负责相应原始数据的检查；
Responsible for checking corresponding raw data according to corresponding SOP requirements.
7、按相应SOP要求，负责相应实验总结报告的检查；
In accordance with the corresponding SOP requirements, responsible for the corresponding test summary report inspection;
8、负责制定相应的QA陈述；
Responsible for formulating corresponding QA statements;
9、按相应SOP要求，负责机构内实验设施的检查；
In accordance with the corresponding SOP requirements, responsible for the inspection of facilities in the organization.
10、参与SOP的制订和审核，并保存所有SOP副本。
Participate in the formulation and review of SOP, and keep all SOP copies.
Assistant to study director （SD助理）
Post duties：
1、药物分析相关专业硕士以上学历；
Master's degree or above in pharmaceutical analysis.
2、有GLP实验室工作及LC-MS/MS使用经验者优先；
GLP lab work and LC-MS/MS experience is preferred.
Tenure requirements：
1、设计并参与I期临床试验中的分析项目；
Design and participate in the analysis of I phase clinical trials.
2、建立化合物定量分析方法并进行验证；
Establish a quantitative analysis method for compounds and verify them.
3、使用药代动力学相关软件进行药代参数的计算；
Use pharmacokinetic software to calculate the pharmacokinetic parameters.
5、负责维护实验室仪器；
Responsible for maintaining laboratory instruments;
6、负责SOP制定及修改；
Responsible for the formulation and revision of SOP;
7、及时与项目经理沟通，解决实验中相关问题。
Communicate with project manager in time to solve related problems in the experiment.
Study Director（SD）
Post duties：
1、药物分析相关专业硕士以上学历；
Master's degree or above in pharmaceutical analysis.
2、生物分析2年以上工作经验；
More than 2 years working experience in biological analysis.
3、熟悉仿制药一致性评价工作；
Be familiar with the consistency evaluation of generic drugs.
4、了解GCP/GLP法规及药品申报流程；
Understand GCP/GLP regulations and drug declaration process;
5、有LC-MS/MS使用经验者优先；
LC-MS/MS experience is preferred.
Tenure requirements：
1、设计并参与I期临床试验中的分析项目；
Design and participate in the analysis of I phase clinical trials.
2、负责生物分析相关的方案及报告的撰写；
Responsible for biologic analysis related plan and report writing;
3、建立化合物定量分析方法并进行验证；
Establish a quantitative analysis method for compounds and verify them.
4、使用药代动力学相关软件进行药代参数的计算；
Use pharmacokinetic software to calculate the pharmacokinetic parameters.
5、负责SOP制定及修改；
Responsible for the formulation and revision of SOP;
6、及时与项目经理沟通，解决实验中相关问题。
Communicate with project manager in time to solve related problems in the experiment.