KEY RESPONSIBILITIES/DUTIES 主要职责:
Provide simple technical or administrative support to assist RA&QA department people. 为RA&QA部门人员提供简单的技术或行政支持。
Quality system function 质量体系方面:
Continuously fully comply with all GMP standard requirements. 持续符合所有GMP标准要求
Assistant to create quality documents and forms. 协助创建质量文件和表单
Assistant to maintain quality records comply with documentation and/or record keeping procedures. 协助维护质量记录,遵守文件和/或记录保存程序。
Distribution and retrieval document hard copy to shop floor.发放和回收纸本文件到生产现场
DCC room tidy up and records package and ship to supplier.文控室整理,记录打包发供应商存储
GMP board maintain on shop floor and routine GMP assessment arrangement and tracking. 现场GMP看板维护,定期GMP评估管理和追踪
Follow all safety policies and requirements.遵守所有安全政策和要求
Other tasks assigned by Supervisor. 主管分配的其他任务
Calibration & Metrology function 校验和计量方面:
Continuously fully comply with all GMP standard requirements; 持续符合所有GMP标准要求;
Assistant to manage gage return, clean up and deliver; 协助管理量具的回收,清洁和发放;
Assistant to generate calibration report; 协助建立校验报告;
Assistant to maintain calibration reports comply with documentation and/or record keeping procedures; 协助质维校验报告,遵守文件和/或记录保存程序。
Gage purchasing information tracking and Gage database collection;量具采购信息追踪和量具数据的收集;
Follow all safety policies and requirements. 遵守所有安全政策和要求
Other tasks assigned by Supervisor. 主管分配的其他任务
PQE function 产品质量方面:
Continuously fully comply with all GMP standard requirements. 持续符合所有GMP标准要求;
Assistant to create quality documents and forms. 协助创建质量文件和表单
Assistant to maintain quality records comply with documentation and/or record keeping procedures. 协助维护质量记录,遵守文件和/或记录保存程序。
Inspection data collection and calculation检验相关数据收集和计算
Follow all safety policies and requirements. 遵守所有安全政策和要求
Other tasks assigned by Supervisor. 主管分配的其他任务
REQUIRED/DESIRED QUALIFICATIONS 任职资格:
High school and above. 中学及以上
College with major in Mechanical is a plus. 大学机械专业优先
Basic verbal and written interpersonal communication skills. 基本的读写和人际沟通技能
Basic PC skills. 基本电脑技能
Good English skill is a plus. 良好的英语技能优先
