PET Technician

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:

大专及以上学历 College or above 具备基本的英语读写能力Basic English in reading & writing GMP 和SHE知识Knowledge of GMP & SHE 组装&包装工艺和操作技能Assembly & Packing process and operation skill 安全、质量和团队意识,具备外资企业制药5年以上生产工作经验者优先 Be aware of safety, quality & collaborate, ability of 5+ years manufacture working experience in foreign pharmaceutical company

Date Posted

23-5月-2024

Closing Date

30-12月-2024

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