工作职责:
1. 负责QC样品和参比品的管理。
Responsible for the management of QC sample and reference product.
2. 负责QC实验室试剂耗材的管理。
Responsible for the management of reagent and consumables for QC laboratory.
3. 负责组内样品保存设备和分装设备的日常维护及采购。
Responsible for the daily maintenance and purchasing of sample storage equipment and dispensing equipment.
4. 负责有关放行检测的委托检验送检,及时协调解决委托检验过程中出现的问题。
Responsible for the commissioned test of release testing. Coordinate and solve the problems in the process of entrusted inspection.
5. 负责整理检测记录和出具相关报告。
Responsible for organizing testing records and issuing relevant reports.
6. 负责QC实验室管理制度类SOP的起草和修订。
Responsible for establishing and revising QC laboratory management procedure.
7. 负责QC实验室偏差的台账更新及归档,处理质量事件处理。
Responsible for maintaining and archiving of QC laboratory deviation investigation logbook. Responsible for handling quality events.
8. 负责QC部门文件管理工作,包括文件目录的更新及现场文件的管理等。
Responsibility for document management including file directory update and on-site file management.
9. 负责QC实验室内审和外审的整改跟踪。
Responsible for tracking the rectification of internal audit and external audit of QC laboratory.
10. 协助合规主管进行QC人员的培训工作,包括QC新员工岗位培训计划制定,QC员工再培训安排,QC员工培训状态统计,QC培训材料的更新和管理。
Assist the compliance supervisor in QC personnel training, including the establishment of QC new employee on-board training plan, QC employee retraining arrangement, QC employee training status statistics, QC training material update and management.
11. 完成上级交办的其他工作。
Complete other works assigned by superior.
任职资格:
1. 大学本科以上或相当学历,药学、生物化学相关专业。具有1年或1年以上制药行业经验。
Bachelor degree or above, major in pharmacy or biochemistry. 1 year or more experience in pharmaceutical industry.
2. 能阅读和撰写英语文件。具备基本的计算机操作技能。
Can read and write English materials. Basic computer skills.
3. 有良好的沟通能力和团队合作精神。
Good communication skills and teamwork spirit.
4. 耐心细致,具有良好的归纳整理能力;条理性强,高效且能同时完成多项任务;较强的自我约束力,独立工作并能承受一定的工作压力。
Patient and meticulous, with good ability of induction and arrangement. Organized, efficient and able to accomplish multiple tasks at the same tim
e. Strong self-restraint, independent and able to work under pressure.