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上海市, 中国
Onsite
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
Roles & Responsibilities / Accountabilities 主要职责/责任
(Major functions of the position) （职位的首要职能）
1. 精益生产、数字化运营与包装流程优化 / Lean Production, Digitalization & Process Optimization
● Lead LPS (Lean Production System) promotion and digital lean initiatives within the packaging area to foster a culture of operational excellence.
主导 LPS（精益生产系统）在包装区域的推广，并推动 数字化精益落地，打造卓越运营文化。
● Lead and implement Kaizen (continuous improvement) initiatives, utilizing SMED (Single-Minute Exchange of Die) to optimize changeover time, line clearance, and material logistics flow.
主导并实 施 Kaizen（持续改进）项目，利用 SMED 工具重点优化设备换线时间、清场流程及物料物流动线。
● Design and deploy low-cost automation (LCIA) and ergonomic solutions to eliminate shop floor wastes and optimize workplace layout.
引入低成本自动化（LCIA）与人机工程学（Ergonomics）解 决方案，消除车间浪费并优化现场布局。
● Lead TPM (Total Productive Maintenance) and OAC (Operator Asset Care) programs to cross-train operators, establishing multi-skilled teams to improve packaging agility.
主导 TPM（全员生产维护） 与 OAC（操作工设备自主维护）项目的开展，建立员工多技能矩阵，以提高包装生产的灵活性。
● Establish, standardize, and continuously optimize workflows (SOPs/Work Instructions) to sustain improvement results and ensure operational consistency.
建立、规范并持续优化工作流程标准化 （SOP/工作指南），以巩固精益改进成果并确保生产操作的一致性。
● Monitor and analyze packaging line performance metrics, track OEE, perform root-cause analysis for downtimes, and coordinate with external departments to develop effective recovery action plans.
监控并分析包装线的绩效指标，追踪 OEE（整体设备效率）及停机根本原因，并协调外部门制定有效的 改善行动计划。
Track and trend all KPI data to identify potential process gaps/risks; take necessary remediation actions with relevant departments to ensure the process remains stable and under control.
对包装的 KPI 进行趋势分析，基于分析结果联合相关部门采取必要的纠正行动，以确保生产过程的稳定可控。
2. 质量、合规与技术风险控制 / Quality, Compliance & Technical Risk Control
● Take ownership of the management, periodic review, and lifecycle updating for general SOPs within the packaging department.
负责包装通用 SOP 的管理、定期审阅及全生命周期更新。
● Assist superiors in handling packaging production quality deviations and investigations; provide support to solve product complaints and establish robust mitigation actions.
协助主管处理包装生产现 场的质量偏差与调查；支持生产部的投诉处理，并通过制定合适的补救与纠正措施来解决问题。
● Support QRM (Quality Risk Management) activities within production, overviewing the end-to-end (E2E) risk assessment and mitigation for each product.
支持生产部质量风险管理（QRM）的相 关行动，确保每个产品端到端（E2E）的风险评估与控制。
● Manage and support CAPA (Corrective and Preventive Action) and Change Control execution within the production workshop.
支持并负责生产部内 CAPA（纠正预防措施）与变更管理的日常执行。
● Ensure all process changes and optimization projects fully comply with GMP regulations, data integrity standards, and global change control procedures.
确保所有的流程变更与优化项目完全符合 GMP 规范、数据完整性要求及变更控制流程。
● Support cross-functional teams (Engineering, QA, Validation) in equipment qualification, packaging material validation, and advanced technical troubleshooting.
配合跨职能团队（工程、QA、验证）完 成设备确认、包装材料验证以及现场技术疑难问题的排查。
● Review and update batch records, logbooks, and master data in related IT systems (such as MES, SAP, Veeva, Cornerstone) affected by process updates.
针对流程与精益更新，负责审查和更新受影 响的批记录、日志及相关 IT 系统（如 MES、SAP、Veeva、Cornerstone）中的主数据。
3.项目独立主导与跨部门项目用户角色 / Project Leadership & Cross-Functional Project User Role
● Independently own, lead, and execute internal optimization and modification projects within the packaging department (e.g., OEE boost, changeover optimization, and waste reduction projects).
独立承担并主导包装部门内部的改良型与优化类项目（如 OEE 提升、换线优化、降本增效等部门内项 目），负责从立项、方案设计到落地执行的全周期管理。
● Act as the core Business/User Role (Key User) in cross-functional projects
在跨部门项目作为包装 部门的核心业务用户（Key User）深度参与。
4. 团队赋能与精益文化建设 / Capability Development & Lean Culture
● Conduct on-site technical training and OJT (On-the-Job Training) for shop floor operators to enhance their understanding of standardized workflows and Lean concepts.
对车间操作员工进行培训，提升 一线员工对标准化工作流及精益理念的认知与实操能力。
● Foster a shop floor continuous improvement culture by coaching frontline teams on how to identify wastes, submit, and execute Kaizen suggestions.
指导一线团队识别现场浪费，培训并鼓励其提交与 执行 Kaizen 建议，在车间内营造全员积极参与持续改进的文化氛围。
5. SHE（安全、健康、环境） / SHE
Act as the packaging SPOC (Single Point of Contact) for SHE-related matters, conducting safety assessments and STARI tracking.
作为 SHE（安全、健康、环境）相关的包装接口人/评估人，负责 安全评估及 STARI 的跟踪。
Qualification and Experience 能力与经验
Education/Qualifications 教育程度/所获资格证书
University or above 本科及以上
Pharmacy, Chemistry, Biochemistry and equivalent 药学、化学、生物化学及相关学科
Leadership Competencies,As the individual contributor and self-leader, self-motivation and good communication skill is preferred
作为一个个人贡献者和自我领导，自我激励和良好的交流能力是必须的
Job Required Competencies 岗位所需胜任力
1.3 Years work experience in quality control, assurance, analysis or equivalent 三年质量控制，质量保证，分析及相关工作经验
2.At least 3 year experience of technical position in pharmaceutical company manufacturing. 至少三年药厂技术岗位工作经验
3.Expertise in the using of PMP & lean tools is preferred 能够熟练运用项目管理和精益生产工具更好
4.Knowledge of GMP GMP 知识 Skills and experience of pharmaceutical production process and in-process control 药品生产与制程控制的技能与经验
Skills of carrying physical test and operating normal instruments 实验与仪器操作的能力
5.Knowledge of Quality management 质量管理的知识
6.Language skill: Good at English, listening, speaking, reading and writing. 语言技能: 具有良好的英语听说读写能力
7.PC skill: Office, Minitab (or equivalent software) 电脑技能: Office, Minitab (or equivalent software)
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
