QC Supervisor-Tissue质量控制主管-组织诊断

Main Tasks & Responsibilities主要工作职责 :

General 日常事务

- Plan, organize and monitor routine tasks and activities within group and lab to fulfill operation in site.
在团队及实验室中计划，组织及监控日常工作任务及活动，满足工厂运营需求。

- Report activities and critical issues to superiors in a timely manner
及时向上级汇报所发生的活动以及重点问题。

- Optimize test process and labor efficiency while meeting required safety and quality levels

保证实验室安全和质量的前提下优化测试流程和提高实验室的效率

- Support and/or implement global manufacturing, quality and business initiatives in compliance with local authority requirements.
支持和/或执行全球化生产、质量及业务的活动，并符合本地监管部门的要求。

Technical transfer 技术转移

- Responsible for build the test capability of tissue diagnostic in QC department. Ensure the process, inspection technology, test capability, equipment, method validation are proper considered and implement in order and in compliance.
负责部门内组织诊断产品测试能力建立，确保在工艺、检验技术、测试能力、仪器、方法验证皆被适当考虑并有序合规的执行

- Transfer quality control related process and procedures from sending site to RDSZ, and coordinate the resources to provide appropriate verification to ensure these procedures are suitable for routine quality control requirement during production as well as local regulation.
负责将转出工厂的质量控制流程及程序转移到苏州工厂，并协调资源将这些程序进行适当的验证以满足制造过程中质量控制要求及当地法规要求。

- Responsible for identify user requirement of equipment for tissue diagnostic product line. Execute equipment selection, purchasing, installation and qualification.
负责依据组织诊断产品的要求识别设备的用户需求，并执行设备的选型、采购、安装及确认工作。

Tissue diagnostic product inspection 组织诊断产品检验

- Responsible for performing pathology staining test for incoming raw material, bulk solutions and finished goods ,include H&E staining and advanced staining. Provide judgement for the slide after staining

- 负责执行原料、半成品、成品相关的病理染色实验，包括H&E染色及高级染色，并对完成染色的切片进行技术判断

- In charge of tissue embedding, cutting paraffin sections，qualify tissue and/or cell pellet blocks and verify qualified slides and storage.
负责组织包埋、石蜡切片切割、鉴定组织和/或细胞块、切片的确认及储存。

- Planning, arranging and monitoring of product release test by qualified person.
计划、安排及监控产品放行测试，由有资质人员执行测试。