工作职责:
1. 负责组织人员进行样品管理、留样观察、稳定性样品的管理。
Be responsible for organizing personnel for sample management, sample observation and stability sample management.
2. 负责安排人员执行取样，包括原辅包、公用介质、环境取样等。现场实施检验项目（如拉曼、气体检测、包材尺寸等）。
Be responsible for arranging personnel to carry out sampling, including APIs,excipients, packages, Utility media, environmental sampling, etc.Inspection items (Such as Raman spectroscopy, Gas detection, Package material size etc.) shall be implemented on site.
3. 负责组织人员完成纯化水、注射用水、工艺气体项目的检测。
Responsible for organizing personnel to complete the testing of purified water, water for injection and process gas projects.
4. 管理委托实验室，委托样品的送检等事项。
Management of contact laboratories, samples delivery.
5. 负责整个质量控制部内部受控文件的收发、整理与汇总以及检验相关记录管理；
Be responsible for receiving and dispatching, sorting and summarizing the internal controlled documents of the whole quality control department, as well as the management of inspection related records;
6. 负责整个质量控制部内部试剂和耗材的预算、采购、保存和管理；
Be responsible for the budget, procurement, storage and management of reagents and consumables within the whole quality control department;
7. 负责质量控制部所有人员GMP培训模块和培训计划的制定和进度跟踪；
Be responsible for the formulation and progress tracking of GMP training modules and training plans for all personnel in the Quality Control Department;
8. GMP审计：负责协调和应对日常客户审计和官方审计。
GMP Audit: Responsible for coordinating and responding to daily customer audits and official audit
9. 制定组的检测工作计划，跟踪计划的实施进度，按期完成检验工作。
Draft the testing plan for the Regulation group, track the process, and complete the testing work on schedule.
10. 负责小组文件的起草、审核。实验室的偏差、变更、CAPA的事项跟踪。
Responsible for drafting and reviewing SOPs.Follow up the deviation, change and CAPA of the laboratory.
11. 负责与其它小组或部门进行沟通，协调跨部门的相关工作。
Responsible for communicating with other groups or departments and coordinating related work across departments.
12. 负责组织检验成本的核算，制定精益化工作措施并实施。起草、审核稳定性试验方案和报告。
Responsible for organizing the accounting of testing costs, establishing the measures on lean production and implementing it.Draft and review the stability study protocol and report.
13. 负责在管辖区内推行5S的管理，并负责管理区域内的检验设备，组织人员开展设备维护保养工作。确保实验室现场设备可正常运行，在有效期内。
Responsible for the implementation of 5S management and equipment management in the jurisdiction of the area, organizing personnel to carry out maintenance of equipment. To ensure that equipment in QC can be operated normally, within the validity period.
14. 完成QC经理分配的其他工作和职责。
Any other job and responsibilities assigned by QC Manager.
任职资格:
1、至少3年QC小组相关的管理经验，至少5年有理化检测经验，有使用过LIMS的经验。
At least 3 years of QC team related management experience, at least 5 years of physical and chemical testing experience, with experience in using LIMS.
2、能够阅读相关的英文资料。
Be able to read related English materials.
3、熟悉FDA/EMA/NMPA等cGMP法规、药典和ICH指南要求。
Familiar with FDA/EMA/NMPA and other cGMP laws, codes and ICH guidelines.