IFB-QC Expert-Method Digitalization 质量控制方法数字化专家

该职位来源于猎聘 搭建实验室LIMS等系统 需要：英文口语流利（与海外沟通） 注意：所示薪资为预算参考值，实际offer将基于候选人资质和当前薪资灵活调整，可能高于或低于标注范围。 我们的团队： InsuLINK项目是一项战略性高预算投资项目，旨在在德国（法兰克福）和中国（北京）建立两个新的胰岛素生产基地。质量控制团队专注于建立、确认和运营这两个工厂所涉及的所有质量控制事项。主要工作包括：确保质量控制实验室的及时建立 / 确保实验室流程的统一协调 / 制定设备安装和确认的方案并编制相应文件 / 准备分析方法转移并跟进执行情况。 主要职责： 质量控制方法数字化专家将为建立数字化IFB质量控制/微生物质量控制（QC/MQC）实验室环境做出贡献，特别是实验室执行系统（LES）。这将与内部现场专家（法兰克福生物园区、IFF、北京制剂工厂和IFB）以及外部合作伙伴密切合作完成。他/她负责协调跨学科、跨职能的项目团队，以实现项目目标和里程碑。他/她还将在此角色中作为关键用户做出贡献，并支持IFB质量控制/微生物质量控制实验室进行LES的评估、实施和优化。

• Project Coordination and Preparation: Preparation and coordination of the LES project from Phase 0 to Gate 3 Release in close collaboration with QC/MQC laboratories, internal subject matter experts, and external service providers. Planning, creation, and tracking of the project plan as well as definition of milestones for Gate 3 planning in alignment with all stakeholders. 项目协调和准备：与质量控制/微生物质量控制实验室、内部主题专家和外部服务提供商密切合作，准备和协调从第0阶段到Gate 3发布的LES项目。规划、创建和跟踪项目计划，以及与所有利益相关者协调定义Gate 3规划的里程碑。
• Project Alignment: Alignment and linkage of IFB with LES/LIMS FBC and LEX/LIMS Beijing DP for QC and MQC topics; participation in relevant cross-project alignment meetings. 项目协调：将IFB与LES/LIMS FBC和LEX/LIMS北京制剂工厂在质量控制和微生物质量控制主题上进行协调和关联；参加相关的跨项目协调会议。
• Method Digitalization and Harmonization: Digitalization, harmonization, and qualification of test methods in the LES context with a focus on product testing, standards, reagents, and instrument management. 方法数字化和协调：在LES环境中对测试方法进行数字化、协调和确认，重点关注产品测试、标准、试剂和仪器管理。
• Candidate Matrix & Method Collection: Collection and documentation of test methods in a candidate matrix including criteria such as sample throughput, complexity, and duration; clustering/grouping of methods for gap assessment. 候选矩阵和方法收集：在候选矩阵中收集和记录测试方法，包括样品通量、复杂性和持续时间等标准；对方法进行聚类/分组以进行差距评估。
• Gap Assessment: Conducting gap assessments of the clustered methods together with the laboratory; benchmarking against global LES templates; identification of gaps and deviations. 差距评估：与实验室一起对聚类方法进行差距评估；与全球LES模板进行基准比较；识别差距和偏差。
• IFB Transfer Management: Creation of an overview of methods that need to be transferred to IFB; review of existing transfer plans; clarification of timelines, dependencies, and IFB requirements. Acting as interface to external consultants, internal customers within the Sanofi network such as ITS, CSV, and the QC/MQC laboratories. IFB转移管理：创建需要转移到IFB的方法概览；审查现有转移计划；明确时间表、依赖关系和IFB要求。作为与外部顾问、赛诺菲网络内部客户（如ITS、CSV）以及质量控制/微生物质量控制实验室的接口。
• Technical Guidance and Coordination: Coordination of Key Users, external companies, and internal departments to achieve project milestones as the central point of contact for the LES project. 技术指导和协调：协调关键用户、外部公司和内部部门以实现项目里程碑，作为LES项目的中心联系点。
• LES Implementation and Training: Supporting units in the implementation of the LES as well as introduction and training on the LES and digital processes within the units. LES实施和培训：支持各单位实施LES，以及在各单位内介绍和培训LES和数字化流程。
• System and Database Management: Processing, maintenance, and optimization of systems/databases (SAP, LIMS, OneLIMS); responsibility for master data management, data analysis, and interfaces to SAP. 系统和数据库管理：处理、维护和优化系统/数据库（SAP、LIMS、OneLIMS）；负责主数据管理、数据分析和SAP接口。
• GMP Documentation: GMP-compliant documentation, creation of Standard Operating Procedures (SOPs), and regulatory-relevant pharmaceutical-technical documentation (e.g., validation/qualification documents). GMP文档：符合GMP的文档编制、标准操作程序（SOP）的创建，以及与监管相关的药物技术文档（例如验证/确认文件）。
• Reporting and KPIs: Supporting the creation of reports and KPIs in a clear and understandable manner to ensure transparency of project progress. 报告和关键绩效指标：以清晰易懂的方式支持创建报告和关键绩效指标，以确保项目进展的透明度。
• Regulatory Compliance: Processing of events, change controls (CCs) & CAPAs; responding to regulatory inquiries and participating in regulatory authority inspections. 法规合规：处理事件、变更控制（CC）和纠正预防措施（CAPA）；回应监管查询并参与监管机构检查。 关键角色：
• Coordinate and define the LES project management strategy, including project plan, tracking mechanisms, and cross-functional alignment with QC/MQC laboratories, FBC-LES team, IFF team and Beijing DP-LES team(D)
• Advise on method digitalization, harmonization, and gap assessment strategy for the IFB-QC/MQC laboratory environment (A)
• Advise on IFB transfer management, including timelines, dependencies, and transfer plan reviews (A)
• 协调并确定LES项目管理策略，包括项目计划、跟踪机制，以及与QC/MQC实验室、FBC-LES团队,IFF团队,北京制剂工厂-LES团队的跨部门协调 (D)
• 就IFB-QC/MQC实验室环境的方法数字化、协调和差距评估策略提供建议 (A)
• 就IFB转移管理（包括时间表、依赖关系和转移计划审查）提供建议 (A) 任职要求：
• About you 任职资格: Experience:
• Experience in quality control, laboratory processes, and GxP requirements and regulations.
• Experience in method digitalization and harmonization in pharmaceutical QC laboratories, preferably experience with Labware.
• The candidate should be able to independently handle the essential workflows in the QC laboratory within the quality assurance systems framework, based on practical experience. 工作经验:
• 在质量控制、实验室流程以及GxP要求和法规方面的经验。
• 在制药质量控制实验室的方法数字化和协调方面的经验，最好有Labware经验。
• 候选人应能够基于实际经验，在质量保证系统框架内独立处理质量控制实验室的基本工作流程。 Soft skill:
• Recognized team player
• Good and transparent communication skills; customer/support/team orientation
• Willingness to perform and assertiveness
• Understanding of "servant leadership"
• Adaptable and flexible in responding to new ideas and changes
• Consistent and quality-oriented
• Courage to challenge the status quo and propose changes
• Open feedback culture as the foundation of collaborative work 通用技能:
• 公认的团队合作者
• 良好且透明的沟通技巧；客户/支持/团队导向
• 工作意愿和果断性
• 理解"服务型领导"
• 适应性强，灵活应对新想法和变化
• 始终如一且注重质量
• 勇于挑战现状并提出变革
• 开放的反馈文化作为协作工作的基础 Technical skill:
• Knowledge of Lab Execution Systems (LES), preferably Labware, and their integration into existing laboratory infrastructures; affinity for electronic systems and applications
• Very good IT skills – particularly SAP, Word, and Excel
• LEAN experience, including process optimization, is desirable
• Good knowledge of fundamental cGMP regulations
• Independent, self-responsible work in accordance with GMP requirements
• Willingness to pursue further training
• Experience in roll-outs of LIMS and Lab Execution Systems as well as project preparation phases (Phase 0 to Gate 3 Release) is desirable 专业技能:
• 了解实验室执行系统（LES），最好是Labware，以及它们与现有实验室基础设施的集成；能够快速适应和掌握电子系统和应用程序
• 非常好的IT技能 - 特别是SAP、Word和Excel
• 具有精益经验，包括流程优化，优先
• 对基本cGMP法规有良好的了解
• 按照GMP要求独立、自主地工作
• 愿意接受进一步培训
• 具有LIMS和实验室执行系统推广以及项目准备阶段（第0阶段到Gate 3发布）的经验者优先 Education: The candidate holds a completed Batchlor degree or above in natural sciences or engineering

教育背景: 候选人持有理学或工学学士学位或以上学历 Languages: English (business fluent / negotiation level) 语言要求: 英语（商务流利/谈判水平） Take the Lead: Aim Higher, Act for Patients, Be Bold, Lead Together

敢为人先: 志存高远，心系患者，敢于创新，聚力同行