岗位描述
在罗氏,我们鼓励每位同事展现真实的自己;我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结,在这里,你将因为做自己而被重视、接纳和尊重,并得到个人的提升和职业的发展。所有的这一切,都是为了更好地预防、阻止和治愈疾病,并确保医疗资源的可及性和可持续性。欢迎加入罗氏,一个重视每种声音的地方。
职位
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)
我们是谁
打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学,确保今天和明天的人们,都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗,我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案,对全球的医疗环境带去推动和影响。
让我们一起,构建更健康的未来。
罗氏提供平等的职业发展机会。