PET Technician
6 months ago
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 companyDate Posted
23-5月-2024Closing Date
30-12月-2024