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
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
Support to setup manufacture system to ensure following BAU smoothly
生产和日常操作
Production and routine operator
Follow GMP & SOP
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
Facilitate problem solving when on duty and escalate if needed
Participate in the deviation & complaint investigation
Packing line Cleaning
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
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
Report equipment abnormal in time and solve complex equipment problems
Participate in general upkeep and lead AM activities
Help equipment maintenance and upkeep with engineer
培训
Training
Accept relative training of GMP&SHE
Train new staff and others’ skills
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
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
Strictly follow GMP SOPs.
Report to line manager or QA about GMP questions encountered in daily work
其它Other tasks
Paper work or report upon request
Functional support
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
07-11月-2024
Closing Date
30-12月-2024
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.