Purpose:

岗位工作地点在青岛， 项目建设期间参与生产部的前期设计，建造，调试和确认等工作，作为用户代表一员支持项目组实现青岛pMDI工厂的建设。通过精益标准化和专业技能持续标准化与改善如SOP/工作指导以确保项目期间的知识，技能和经验能够传承以支持未来的商业化生产，并在项目早期就注重工艺/设备/操作等的持续改善工作。

进入商业化生产期间，高质量地实现所有设定的生产目标，包括设备的操作和基本维护，生产线的清场，及技能的发展等。

This role is based in Qingdao. During project phase involved in product department Design, Construction, Commissioning and Qualification. As an end user to support Global engineering team/Project team to deliver Qingdao pMDI project. And standardize knowledge and experience during project and startup phase to prepare for Qingdao site PQ and PV and ensure following BAU smoothly in terms of daily operation including SOP/WI ready and continuously improve process/equipment/operation from project to BAU transition.

Fulfill all set production objectives in respect of equipment operation & basic maintenance, line clearance, and skill development. etc.

作为最终用户参与和支持青岛工厂的项目建设

Support project team to deliver Qingdao pMDI project as end user

• 参与到生产部门的设计、安装、调试等工作，支持到商业化生产的能力建立。

Involved in product department design, installation, commissioning etc., BAU capability build up

• 学习并运用其他工厂和行业的最佳实践到新工厂

Learn and apply best practice from other sites and other experiences to Qingdao projects

• 通过项目期间的参与，实践为未来的商业化生产的垂直启动和成功做好充足的准备

Prepare vertical startup of BAU through expertise, lean and experience gained from project phase

• 良好的问题解决能力和持续改进的能力，支持项目C&Q,PQ/PV的成功

Strong PPS and CI capability to support C&Q, PQ/PV successfully

• 支持生产体系的搭建以支持未来的商业化生产

Support to setup manufacture system to ensure following BAU smoothly

生产和日常操作

Production and routine operator

• 遵守GMP和SOP的相关规定

Follow GMP & SOP

• 遵守公司政策

Follow AstraZeneca policy

• 能够独立操作各生产工段（配料、制剂、罐装、组装线、包装线）和IPC设备，明确岗位职责并考取岗位上岗证

Able to each production section (dispensing, formulation, filling, assembly lines, packaging lines)operate Assembly line machine、 Packing line machine and IPC machine ,and know the job responsibility and get the job certificate

• 熟知岗位中间控制职责，如果经过中间控制知识及操作技能的培训并考核合格后，承担生产过程中的中间控制职责

Familiar with in-process-control, take the IPC responsibility if finish IPC training and pass the test

• 及时向流程负责人/一线生产经理反馈当班过程中的人员行为和绩效，必要时对员工进行辅导

Report to process facilitator/FLM about people behavior and performance when on duty, coach employees if needed

• 自主解决当班过程中产线的各种问题解决，必要时升级

Facilitate problem solving when on duty and escalate if needed

• 参与偏差和投诉等质量事件调查

Participate in the deviation & complaint investigation

• 进行生产线的清洁、清场

      Packing line Cleaning

• 积极主导现场问题的解决，并协调生产资源

Actively lead problem solving in line and coordinate line resource

• 具备相应的精益技能和意识，并提出改善建议，组织产线持续改进项目实施

Propose continuous improvement ideas based on lean skills and mindset, lead improve project execution

• 保持现场良好的5S状态

Keep good 5S status in shopfloor

    TPM

• 确保员工按照点检表要求进行点检，并不断优化点检内容

Ensure employees follow the spot check form and continuously improve the form

• 及时报告设备的异常，并能独立解决复杂设备问题

Report equipment abnormal in time and solve complex equipment problems

• 参与设备的日常保养并主导AM活动

Participate in general upkeep and lead AM activities

• 协助维修人员进行设备的维修和保养

Help equipment maintenance and upkeep with engineer

培训

Training

• 接受相关GMP和SHE的培训

Accept relative training of GMP&SHE

• 培训新员工和其他人员岗位操作技能

Train new staff and others’ skills

• 掌握多技能，并推进产线员工多技能发展

Have multi-skills and promote employees’ multi-skill development

• 组织培训资料的编写和操作标准的制定，并检查标准是否执行到位

Organize drafting training materials and process standard, regularly do standard confirmation

• 能够独立编写GMP相关文件，如SOP WI等

Can draft GMP related documents such as SOP WI

GMP 要求

GMP requirements

• 理解业务活动中涉及GMP的相关内容及可能对产品质量产生的影响

Understand the impacts of daily work on GMP requirements and product quality

• 参加GMP相关培训，确保业务活动持续符合GMP要求

Attend GMP trainings and ensure that daily work is compliant to GMP consistently

• 严格执行本岗位的GMP相关规程

Strictly follow GMP SOPs.

• 向直线经理或QA沟通工作中遇到的GMP相关问题 

Report to line manager or QA about GMP questions encountered in daily work

其它Other tasks

• 根据工作需要完成文件工作

Paper work or report upon request

• 提供跨部门支持

Functional support

• 文件工作

Documentation

Requirements:

• 药学或理工科相关专业本科学历及以上Bachelor degree or above with pharmaceutical or Engineering related background
• 具备基本的英语读写能力Basic English in reading & writing
• 能应用微软常用办公软件Basic Microsoft office skill
• 个人特性Personal character
• ➢与团队成员真诚交流
• Be honesty to communicate with each other in team
• ➢在高强度工作压力下具有很强的责任感
• Be responsibility under high work pressure
• ➢团队工作精神，乐于分享
• High team work spirit and be willing to share