Shift leader
- 这是中国新 pMDI 制造工厂前沿项目的生产班长职位。
职位任职者将
• 参与实施以确保 pMDI 项目进度。
• 负责确保青岛资本项目计划在设计、建设、启动、验证(整个生命周期)期间、任职者能够明确岗位的工作目的工作性质及范围,主要职责包括SHE、GMP相关技能及对应培训需求、有助于使用者明确自身岗位职责
•确保完全符合 AZ 标准和当地法规。
任职者能够完成日常活动并与部门内外良好合作,交流相关信息和最新情况积极与同事沟通。
以自信包容的态度支持一线经理管理团队完成工作
This is a role as the shift leader in the leading edge project of new pMDI manufacturing facility in China
The role incumbent will
• Participate in implementation to ensure the progress of the pMDI project.
• Responsible for ensuring that the Qingdao capital project plan is in design, construction, start-up, and validation (throughout the life cycle). The incumbent can clearly understand the purpose, nature and scope of the job. The main responsibilities include SHE, GMP related skills and corresponding training needs, which helps users to clarify their job responsibilities
• Ensure full compliance with AZ standards and local regulations.
The incumbent can complete daily activities and work well within the department and cross function, exchange relevant information and updates and actively communicate with colleagues.
Support the front-line manager management team to complete the work with a confident and inclusive attitude 职责(包括关键结果领域、具体责任、任务等) Job Responsibilities (to include key result areas, specific accountabilities, tasks, etc.)
- 帮助建立所在区域BoSHE、SHE 危害卡和十大风险,参与pMDI 设备PSSR,支持完成SHE风险热力图可视化。
- 支持确保区域安全,及时制止不合规操作和行为。并报告工作中发生的任何事故和隐患。积极发现问题和改进点并提出改进措施。
- 能够在自己领域培训他人 SHE 知识,推广良好的 SHE 文化。
- 严格遵守 SOP/WI 和 GMP 要求,通过质量关注和质量分享等方式确保区域内践行一次做对、从我做起的原则以及区域内的良好质量表现。
- 熟悉过程控制,承担IPC职责,在项目阶段建立质量关键控制点和SME培训包。
- 能够带领试机并协助协调区域内相关的 C&Q 等质量相关活动。
- 及时报告质量问题和偏差,确保按照流程升级风险/问题并促进有效解决问题。
- 参与并能独立完成次要偏差及投诉调查。
- 起草并优化生产流程中的SOP、WIs文件及作业操作相关文件的起草,并能支持线一线经理审核批记录相关文件。
- 严格执行确保团队按照 SOP/WI 要求执行生产线清场与清洁。
- 协助带领参与pMDI 生产线设计、设置以满足项目进度,能够在多个岗位上操作,并领导生产线问题解决和协调生产线资源,包括FAT、SAT 和相关 CQV 和 BAU 阶段。
- 整理、标准化pMDI相关专业知识,建立SME及培训包,能够主导本班次现场生产活动相关的内外部协调工作,确保生产活动的持续、顺利进行。
- 关注生产流程,能够确定优先事项,并能够协调人力资源和生产计划等方面。擅长MES系统,积极识别流程、设备、材料等方面的改进机会。主导和参加层级会议,根据流程升级风险/问题,寻求资源跟踪以促进问题的解决。
- 参与和带领生产线的保养和维护,帮助建立 AM 和 CLIT 标准,参与早期设备管理阶段,帮助将 TPM 思维深入一线,并成为 TPM 榜样,根据项目和 BAU 积累的经验来满足 pMDI 项目垂直启动和 BAU 相关要求。
- 支持一线经理进行产线管理,支持多技能发展,注重团队内部的持续学习,不断提高团队的技能,培训和培养一线员工。支持对生产线员工进行适当辅导,并向一线经理提供员工行为和绩效反馈。
- 敏捷主动地适应变化, 善于应用精益方法和思维提出持续改进,主导改进项目执行。积极参与组织员工活动,加强员工关系管理,增强团队员工凝聚力。
- 组织Genba管理,能够利用数据和风险管理快速解决问题。推动标准化工作,识别流程浪费并持续改进。能够应用精益数字化方法提高生产效率和质量。
- 积极推动精益数字化工具应用,加速实施青岛autonomous factory的发展,并能够熟练使用所在领域的系统(如SAP、Pas-x、Systec、Tacksys等)和数字化工具,指导/培训他人使用数字化工具,积极支持和参与数字化学习和培训。
- Help establish the BoSHE , SHE hazard card and top 10 risk in area and do the PSSR for the pMDI machine and make the SHE heat map visualized
- Lead and support on ensure the safety of area and promptly stop non-compliant operation and behavior. and report any accidents and hazards in the work. Actively identify problems and improvement points and propose improvement measures.
- Train others on SHE knowledge in their own areas, and promote the good SHE culture
- Strictly follow SOP/WI and GMP requirement to ensure right first time and right from me principle and good Quality performance in area through quality focus and sharing.
- Familiar with in-process-control, take the IPC responsibility establish the quality critical control points and SME training package during the project phase
- Lead the trail run and help coordinator the C&Q activities in area
- Report quality issue and deviations in a timely manner and ensure the Escalate risks/issues according to the process and promote effective problem solving.
- Participating and can lead for minor deviation & complaint investigation
- Draft and optimize SOP and WIs documents in production processes and draft documents related to job operations, and can support on line manager review the Batch record related documentation.
- Implementing and ensure Line cleaning and clearance by strictly follow SOP/WI
- Support lead for pMDI line design, setup to meet project progress, be able to operate the in multiple position, and lead problem solving in line and coordinate line resource not only for FAT,SAT and related CQV and BAU phase.
- Organize and standardize pMDI related expertise and knowledge, establish SME and training packages, and be able to lead the internal and external coordination work related to on-site production activities of this shift to ensure the continuous and smooth operation of production activities.
- Focus on production process, be able to determine priorities, and be able to coordinate production regarding manpower resources and production scheduler, etc. good at MES system actively identify opportunities for improvement in processes, equipment, materials, etc. facilitate and participate in Tier meeting to Escalate risks/problems based on processes, seek resource tracking to promote problem solving.
- Lead and Participate in line operation and maintenance, help establish on AM and CLIT standard, participate in early equipment management phase to help embed TPM mindset into shopfloor level and be a TPM role model to meet pMDi project startup and BAU requirement based on project and BAU experience
- Support line manager on line management, support on multi-skill development, focus on continuous learning within the team, continuously improve the team's skills, Train and develop frontline employees. Support on coach to employees on the production line and provide the Behavior and performance feedback to FLM.
- Agile to adapt to change quickly and proactively, propose continuous improvement ideas based on lean skills and mindset, lead improve project execution. Actively participate in organizing employee activities, strengthen employee relationship management, and enhance employee cohesion
- Facilitate Genba walk, to quickly solve problems using data and risk management. Drive standardized work, identify process waste, and continuously improve. Able to apply lean digital methods to improve production efficiency and quality.
- Actively promote lean digital tools to accelerate the development of AZQD autonomous factory, and be able to skillfully use the systems(such as SAP, Pas-x, Systec, Tacksys etc) and digital tools in his/her area, guide/train others to use digital tools, and actively support and participate in digital learning and training.
典型职责(根据 AZ 框架和监管要求)Typical Accountabilities (per AZ framework and regulatory expectations)
- 开展符合公司价值观的活动和互动,并遵守与您的职位相关的道德规范和支持政策和标准(包括 SHE)。按时完成 AZ 道德规范和支持政策和标准的所有必需培训。报告潜在的不合规问题。
- Conduct activities and interactions consistent with Company Values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role (including SHE). Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.
- 教育、资历、技能和经验Education, Qualifications, Skills and Experience
必备条件Essential
- 安全、质量和团队意识,具备生产操作或者外资企业制药6年以上生产工作经验者优先
- SHE,GMP 和精益生产知识
- 具备基本的英语读写能力
- 能应用微软常用办公软件
- 诚信,正直,具备良好沟通能力
- Be aware of safety, quality & collaborate, ability of production operate, prior with 6+ years manufacture working experience in foreign pharmaceutical company
- Knowledge of GMP & SHE& Lean
- Basic English in reading & writing
- Basic Microsoft office skill
- Honesty, integrity and good communication skills
优先条件Desirable
- 具备班组生产协调、设备操作及设备维护方面的工作经验
- pMDI设备和流程相关经验
- SAP和MES相关经验
- 拥有相关项目或者新工厂经验
- 大专以上学历和较好的应用背景
- Have working experience of production coordinate、machine operate & equipment maintenance
- pMDI production knowledge
- SAP and MES experience
- Have project or new site startup related experience
- College or above and have English background
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 authorisation and employment eligibility verification requirements.