具体职责/任务

Specific Responsibilities/Tasks

• 与配料、制剂、罐装、组装、包装的流程执行一线经理和专家以及项目组来总结和可视化现行的生产流程

Work together with  dispensing、formulation、filling、A&P  process facilitators and SME and project member to summarize and visualize the current production process.

• 根据药品生产质量管理规范和PAS-X可执行批生产记录的理念将生产流程进行系统语言转化,并能实现流程的简化以及标准化。Transfer the production process based on GMP requirements and PAS-X MBR design concept into system design especially in the way of simplification and standardization.
• 与流程执行团队一起共同推进PAS-X系统，以使工厂实现电子批记录和物料追踪

Lead PET to roll out PAS-X system to enable Qingdao site EBR/material flow tracking.

• 与流程执行团队一起共同推进过程控制系统如PCS7，以实现青岛工厂制剂工艺的稳定运行

Lead PET to roll out process control system like PCS7 to enable formulation process of Qingdao site run steadily

• 与流程执行团队一起共同推进追溯系统，以实现青岛工厂产品的可追溯性

Lead PET to roll out traceability system to enable traceability of Qingdao site products

• 与流程执行团队一起共同推进自动化系统的应用, 比如LES、大数据课题Data Historian &  Discoverant以及质量系统等。

Can take some sub-stream project tracking responsibilities i.e.  LES Big  data related-Data Historian & Discover ant and Quality system etc…

• 撰写数字自动化系统方面的SOP和工作指导文档并持续确保最新的版本给到用户

Draft digital & automation system documents such as SOP 、WI and continuously ensure the latest effective version to all of users

• 负责自动化软件的管理、预防性/故障维护活动，并根据GMP,CGMP,SHE和生产的要去对自动化程序进行开发和维护：

Responsible for automation software management 、preventive /restorative maintenance activities,

负责自动化软件及设施的管理和维护

Responsible for the management and maintenance of automation software and facilities

负责自动化系统的升级和改进

Responsible for the upgrade and improvement of the automation system

• 对设备运行进行优化，以提高生产力和稳定性

Optimize equipment operation to improve productivity and stability

• 对新项目新设备进行研究，编写相关的材料（用户需求、规格说明书）

Research on new projects and new equipment, and prepare relevant materials (user, specifications)

负责自动化程序的备份

Responsible for the backup of the automated program

参与或领导新的项目，提出推荐方案，实施解决方案，以确保项目达成预期

Participate in or lead new projects, propose proposals, and implement solutions to ensure that the project meets expectations

编写自动化程序的SOP和工作指导

Write SOPs and work instructions for automated programs

通过培训分享提高团队的技能

Improve the team's skills through training and sharing

• 在进行一切与业务相关活动时都严格遵守公司 GMP、SHE、合规及其与职位和职责相关的支持性政策与标准

Conduct all business activities in compliance with the GMP /SHE/Compliance supporting Policies and Standards related to position and responsibilities

• 日常工作中与带班/生产负责人/流程团队成员紧密协调

Well coordinate with group leader/PF/PCO members in daily operation