岗位描述
岗位职责:样品的管理流程Sample management procedure1.负责样品的管理职责,且具有较强的沟通能力和总结能力;Responsible for managing the samples, good communication ability and summarization ability.2.负责起草和制定样品管理相关文件,包括相关SOP和其他文件。Responsible for drafting and defining the document of the sample management, such as relevant SOPs and other documents.日常测试样品的管理 Routine samplemanagement根据样品管理SOP要求,包括测试样品的接收,入库,分发管理等。Responsible for the routine testing samples management according to the SOP requirements, including sample receiving, storage and distribution, etc.标准品管理Reference standard management标准品的收发,分装,贴签,保存对应的温度,定期盘库。Receiving, dispatching, dispensing, labeling, storage of corresponding temperature and regular inventory for reference standard.稳定性样品管理Stability sample management1.按照稳定性方案的要求按时,合规地开展稳定性研究,包括稳定性样品的分装,入库,取样,送检,库存点和剩余稳定性样品的管理等。Responsible for starting stability study in a compliant and timely manner according to stability protocols,including stability samples aliquoting storage, pulling, delivery for testing, inventory check and remainingstability samples management, etc.2.负责稳定性研究的建立和持续维护,包括批次选择,检项确认,稳定性时间点设计等。Responsible for stability plan establishment and maintenance, including batch selection, stability indicating assay confirmation to time points design.3.建立和持续更新稳定性研究模板,对进行中的稳定性研究进行追踪,并及时更新稳定性数据。为产品效期的制定提供科学依据。Creation of the effective and clear tracking chart and update template of stability study status, on-time tracking of stability study and regular update of the study status proactively. Stability data analysis usingstatistical software to provide scientific rationales on the shelf-life determination.其他Others协助主管完成其他安排的工作等(如有)Assistant the other duties assigned be the supervisor(when applicable)