职位概述： 负责质量控制（QC）实验室LES系统的功能拓展、测试/确认、Recipe编辑、用户培训/答疑及系统生命周期管理 Responsible for quality control (QC) LES system function improvement, testing/verification, recipe configuration, user training/Q&A and system lifecycle management. 岗位职责： 参与质量控制（QC）LES系统的功能设计，测试/确认，确保系统功能满足用户需求 Participates in functional design, testing/validation of Quality Control (QC) LES system to ensure system functionality meets user needs. 维护计算机化系统的SOP及其附属文件，确保系统使用和配置符合行业cGMP标准和法规要求。 Maintain SOPs and ancillary documents for computerized systems to ensure system usage and configuration meets industry cGMP standards and regulatory requirements. 确保在系统生命周期内系统的管理和维护系统静态数据，并进行必要的审核 Ensure management and maintenance of system static data during the system lifecycle and perform necessary reviews. 协助处理计算机化系统相关质量事件，包括但不限于：偏差、变更和CAPA Assist in handling quality events associated with computerized systems, including but not limited to: deviations, changes, and CAPAs. 培训用户进行系统使用，并及时解答用户在系统使用过程中遇到的问题 Train users to use the system and answer questions they encounter during system use. 应用 WBS(Wuxi Business System) 工具优化工作流程，提高生产力，解决问题。 Apply WBS (Wuxi Business System) tools to optimize workflow, improve productivity and solve problems. 支持和参与公司内外部审计及法规审计。 Support and participate in internal/external ******s and regulatory audits. 任职要求： 教育背景: 本科及以上学历，生化、化学或相关专业背景。 BS degree or above in biochemical, chemistry or related scientific field. 工作经历: 3年以上工作经验，具有GMP体系、计算机化系统管理、及LES管理相关工作经验或其他同等工作经验者优先。 More than 3 years working experience, working experience related to GMP, computerized system management, LES system management or other equivalent working experience is preferred. 专业知识及技能要求: 了解制药行业QC/分析实验室业务流程，能梳理业务规则并将其转化为系统逻辑。 Understanding QC/Analytical Laboratory Business Processes in the Pharmaceutical Industry, and be able to tease out business rules (such as skill matrix, priority rules, device availability) and translate them into system logic. 了解计算机化系统相关法规要求，如CFR21 Part11，欧盟GMP附录11等。 Familiar with Computerized System related regulatory, such as CFR21 Part11, EU GMP Annex 11, etc.. 了解制药行业质量控制实验室系统（如SAP, LIMS, LES等）的接口 。 Understand the interface of pharmaceutical industry quality control laboratory systems (such as SAP, LIMS, LES, etc.). 熟练使用数据分析工具和可视化工具（Power BI）。 Familiar with data analysis tools and visualization tools (PowerBI). 其他技能或经验要求: 沟通能力：与业务团队协作，明确需求并解释技术方案。 Communication Skill: collaborate with business team to identify requirements and explain technical solutions. 问题解决：快速定位问题（如资源不足、规则矛盾）并提出妥善的方案。 Problem resolution Skill: quickly locate issues (e.g., inadequate resources, conflicting rules) and propose appropriate solutions. 项目管理：熟悉敏捷开发或传统项目管理方法，协调开发、测试/验证、上线流程。 Project Management Skill: Familiar with Agile development or traditional project management methods, coordinate development, testing/validation, go-live processes.