Quality Systems & Digitalization Specialist

• Support the operation, compliance, validation lifecycle, and continuous improvement of site quality systems in a regulated GxP manufacturing environment, including LIMS, LES, ARMS, MODA, and related applications. 在受监管的 GxP 生产环境中，支持现场质量系统的运行、合规、验证生命周期及持续改进，包括 LIMS 、 LES 、 ARMS 、 MODA 等相关应用。

• Ensure stable day-to-day operation of assigned GxP quality systems and provide timely troubleshooting, user support, issue coordination, root-cause follow-up, and documentation for incidents and service requests. 确保所负责 GxP 质量系统的日常稳定运行，并针对系统事件和服务请求提供及时的问题排查、用户支持、问题协调、根因跟进及记录维护。

• Support access management, master data coordination, configuration updates, periodic review activities, system health monitoring, audit trail/data integrity related checks, and operational evidence maintenance. 支持权限管理、主数据协调、配置更新、周期性审核、系统健康状态监控、审计追踪 / 数据完整性相关检查及运营证据维护。

• Execute and support computerized system validation activities in accordance with approved procedures, validation plans, risk-based approaches, and applicable GxP

. 依据已批准流程、验证计划、基于风险的方法及适用 GxP 要求，执行并支持计算机化系统验证活动。

• Prepare, review, or maintain validation and lifecycle documents, including URS, CSA, FS, DS, CS, FRA, OQ/PQ, implementation plans, test scripts, validation summaries, SOPs, and periodic review documents. 准备、审核或维护验证及生命周期文件，包括 URS 、 CSA 、 FS 、 DS 、 CS 、 FRA 、 OQ/PQ 、实施计划、测试脚本、验证总结、 SOP 及周期性审核文件。

• Support IT change control, deviation investigation, CAPA follow-up, risk assessment, validation impact assessment, and audit readiness for assigned systems. 支持所负责系统的 IT 变更控制、偏差调查、 CAPA 跟进、风险评估、验证影响评估及审计准备。

• Identify opportunities to improve laboratory and quality processes through digitalization, automation, reporting, data analysis, and system configuration optimization. 识别通过数字化、自动化、报表、数据分析及系统配置优化提升实验室和质量流程效率的机会。

• Support practical improvement solutions using Excel, Power Automate, SQL, dashboards, reporting, and approved system functions, while ensuring alignment with applicable procedures and compliance expectations. 利用 Excel 、 Power Automate 、 SQL 、看板、报表及已批准系统功能，支持可落地的改进方案，并确保符合适用流程和合规要求。

• Support LIMS/LES-related projects, system upgrades, interface testing, validation execution, CR tracking, project reporting, hypercare support, and production deployment activities. 支持 LIMS/LES 相关项目、系统升级、接口测试、验证执行、 CR 跟踪、项目汇报、上线后支持及生产上线活动。

• Prepare clear project updates, meeting minutes, action item tracking, risk logs, issue logs, and management-ready documentation to support transparent communication and decision making. 准备清晰的项目更新、会议纪要、行动项跟踪、风险清单、问题清单及适用于管理层审阅的文件，以支持透明沟通和决策。

• Coordinate with QC, QA, Manufacturing, Engineering, Supply Chain, global IT teams, and external vendors to deliver assigned activities on time and escalate risks, blockers, or compliance concerns in a timely and fact-based manner. 与 QC 、 QA 、生产、工程、供应链、全球 IT 团队及外部供应商协作，确保所负责工作按时交付，并以事实为依据及时升级风险、阻碍或合规问题。

• Support internal and external audits and regulatory inspections by preparing audit-ready documentation, coordinating evidence collection, responding to auditor inquiries related to GxP computerized systems, and following up on audit findings and CAPA closure in a timely manner. 支持内部及外部审计与法规检查，包括准备可审计状态的相关文件、协调证据收集、回应审计人员针对 GxP 计算机化系统的问询，并及时跟进审计发现及 CAPA 关闭。

• Perform other tasks assigned by supervisor. 完成上级安排的其他工作。 Education/ Professional Qualification 学历/专业资格 Bachelor’s degree or above in Computer Science, Information Systems, Pharmaceutical Science, Biotechnology, Engineering, Automation, or other related disciplines; knowledge of pharmaceutical GxP processes and computerized systems is preferred. 计算机、信息系统、制药、生物技术、工程、自动化或其他相关专业本科及以上学历；具备制药GxP流程及计算机化系统相关知识者优先。 Technical/Skills Required 技术/技能需求 Experience supporting GxP quality systems such as LIMS, LES, ARMS, MODA, and other related site quality or laboratory applications. LIMS、LES、ARMS、MODA及其他相关现场质量或实验室GxP系统的经验。 Ability to perform system troubleshooting, user support, data review support, basic configuration coordination, documentation, issue follow-up, and operational evidence maintenance. Good understanding of CSV lifecycle, GAMP 5 principles, data integrity, audit trail, electronic records/electronic signatures, change control, deviation/CAPA, and applicable GxP compliance requirements. CSV生命周期、GAMP 5原则、数据完整性、审计追踪、电子记录/电子签名、变更控制、偏差/CAPA及适用GxP合规要求。 Experience preparing or maintaining validation lifecycle documents such as URS, CSA, FS, DS, CS, FRA, OQ/PQ, implementation plans, test scripts, validation summaries, SOPs, and periodic review documents. URS、CSA、FS、DS、CS、FRA、OQ/PQ、实施计划、测试脚本、验证总结、SOP及周期性审核文件等验证生命周期文件的经验。 Practical skills in Excel, Power Automate, SQL, dashboards, reporting, and approved system functions are preferred to support process improvement and operational efficiency. Excel、Power Automate、SQL、看板、报表及已批准系统功能的实际应用能力者优先，以支持流程改进和运营效率提升。 Working Experience 工作经验 5+ years of experience working on validated applications, GxP IT systems, quality systems, laboratory systems, digital quality solutions, or computerized system validation in a pharmaceutical or regulated environment. 在制药行业或受监管环境中，具备5年以上验证系统、GxP IT系统、质量系统、实验室系统、数字化质量解决方案或计算机化系统验证相关工作经验。 Experience supporting LIMS/LES-related projects, system upgrades, interface testing, validation execution, change request follow-up, hypercare support, and production deployment is preferred. 具备支持LIMS/LES相关项目、系统升级、接口测试、验证执行、变更请求跟进、上线后支持及生产上线经验者优先。 Language, Computer Literacy, Office Software, etc. 语言能力，电脑知识，办公软件等 Good written and verbal communication skills in both Chinese and English, with the ability to prepare clear documentation, meeting minutes, and project updates. 具备良好的中英文书面及口头沟通能力，能够准备清晰的文件、会议纪要及项目更新。 Good computer literacy and proficiency in common office software and collaboration tools, including Microsoft Office; experience with reporting or ticket/service management tools is preferred. 具备良好的计算机基础及常用办公软件和协作工具能力，包括Microsoft Office；具备报表或ticket/service管理工具使用经验者优先。 Others 其他 Strong ownership, learning agility, execution discipline, problem-solving mindset, compliance awareness, and attention to documentation quality. 具备强责任心、学习能力、执行力、问题解决意识、合规意识及文件质量意识。 Good communication and collaboration skills, with the ability to coordinate with business users, QA, QC, IT infrastructure, global application teams, and vendors. 具备良好的沟通与协作能力，能够协调业务用户、QA、QC、IT基础架构、全球应用团队及供应商。 Ability to work independently in a compliance-driven environment, prioritize issues appropriately, and maintain complete and audit-ready evidence. 能够在合规驱动的环境中独立开展工作，合理判断问题优先级，并维护完整、可审计的证据。 百济神州全球胜任力 当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. ●Fosters Teamwork ●Provides and Solicits Honest and Actionable Feedback ●Self-Awareness ●Acts Inclusively ●Demonstrates Initiative ●Entrepreneurial Mindset ●Continuous Learning ●Embraces Change ●Results-Oriented ●Analytical Thinking/Data Analysis ●Financial Excellence ●Communicates with Clarity 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. 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