计算机化系统管理SME （助理研究员1-研究员2，LIMS方向）

1. 01

   参与质量控制（QC）LIMS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) LIMS system to ensure system functionality meets user needs.

2. 02

   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

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3. 03

   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

4. 04

   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

5. 05

   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

6. 06

   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.

7. 07

   支持和参与公司内外部审计及法规审计。 Support and participate in internal/external clients 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： 1年以上工作经验，具有GMP体系、计算机化系统管理、及LIMS管理相关工作经验或其他同等工作经验者优先 1 years working experience, working experience related to GMP, computerized system management, LIMS system management or other equivalent working experience is preferred 专业知识及技能要求：

8. 01

   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

9. 02

   了解计算机化系统相关法规要求，如CFR21 Part11，欧盟GMP附录11等；有计算机化系统验证经验者优先 Familiar with Computerized System related regulatory, such as CFR21 Part11, EU GMP Annex 11, etc. Candidates with experience in computerized system validation are preferred

10. 03

    了解制药行业质量控制实验室系统（如SAP, LIMS, LES等）的接口。 熟悉计算机化系统搭建和升级的底层逻辑者优先 Understand the interface of pharmaceutical industry quality control laboratory systems (such as SAP, LIMS, LES, etc.) Candidates who are familiar with the underlying logic of computerized system setup and upgrade are preferred.

11. 04

    熟练使用数据分析工具和可视化工具（如Power BI），具备一定的编程能力者优先 Familiar with data analysis tools and visualization tools (e.g Power BI). Candidates with certain programming skills are preferred. 其他技能或经验要求：

12. 01

    沟通能力：与业务团队协作，具备一定的沟通谈判技巧及快速识别沟通难点的能力，情绪稳定，逻辑清晰。 Communication Skill: Collaborate with the business team, possess certain communication and negotiation skills, and the ability to quickly identify communication challenges; maintain emotional stability and clear logic.

13. 02

    问题解决：快速定位问题（如识别用户需要解决的需求，引导用户清楚的描述问题）并提出妥善的方案。 Problem resolution Skill: Quickly identify issues (such as recognizing the user's needs to be addressed and guiding the user to clearly describe the problem) and propose appropriate solutions.

14. 03

    项目/需求管理：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。具备一定的需求管理能力，能够合理整合和跟踪需求，对负责的任务进行拆解并保证按时完成，合理安排手头工作。 Project Management Skill: Possess certain project management skills, able to break down tasks to complete milestones, decompose the tasks responsible for, ensure timely completion, and reasonably arrange the work at hand Familiar with Agile development or traditional project management methods, coordinate development, testing/validation, go-live processes.

15. 04

    开发技能：熟练掌握Python/C++/C# 其中任意一项开发语言，负责RPA程序的开发，有AI应用经验者优先。 Development skills：Proficient in at least one of the following programming languages: Python, C++, or C#. Responsible for RPA (Robotic Process Automation) development. Experience with AI applications is preferred.