实验室计算机化系统管理员（助研1-研2，LES方向）

岗位职责

主要角色和职责

1. 根据质量控制（QC）实验室业务需求，参与执行系统（LES）的系统运维，模板编辑，用户培训等，以确保系统功能及业务流程满足既定需求。

Participates in the maintenance, functional design, template editing and user training of LES system based on Quality Control (QC) business to ensure system fulfills the designed purposes.

2. 维护计算机化系统的cGMP体系文件，协助处理计算机化系统相关质量事件（如偏差、变更和CAPA等），确保系统运维/改进等符合法规要求。

Maintain cGMP-related document for computerized systems, assist in handling quality events such as deviations, change controls and CAPAs, ensuring the system maintained and configured properly towards regulatory requirements.

3. 运用运营管理工具或数字化工具（可视化、数据库、自动化算法与AI技术等）改进传统实验室业务流程，提高生产力。

Capability to employ operations management or digitization tools (visualization, database, automation or AI) to enhance tradition business workflow and to improve productivity.

4. 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

(学历要求 + 专业背景)

本科及以上学历，生物学、医学、药学、化学相关背景

BS degree or above in biology, medicine, pharmacy, chemistry, related scientific field

工作经历

(工作年限/专业经验/ 行业经验/ 管理经验)

1年以上工作经验，其中包括一年以上QC/分析实验室检测经验（产品测试方向）

1+ Years working experience, including 1 year experience in QC or analytical lab testing (product testing field)

专业知识及技能要求

1. 了解制药行业QC/分析实验室业务流程（产品测试方向），能梳理业务规则并将其转化为系统逻辑。

Understanding QC/Analytical Laboratory Business Processes (product testing field) 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

2. 熟悉业内的实验室系统（如SAP, LIMS, ELN, LES等）；

Familiar with the industry laboratory systems (such as SAP, LIMS, ELN, LES, etc.)

3. 经过培训或具有满足 NMPA、 EMA 和 FDA 等 GMP 法规要求的相关经验。

Must be trained or have experience to meet the GMP regulations of NMPA, EMA and FDA, etc.

其他技能或经验要求

1. 沟通能力：与业务团队协作，明确需求并解释技术方案的能力。

Communication Skill: collaborate with business team to identify requirements and explain technical solutions.

2. 问题解决能力：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.

3. 可以熟练的阅读、撰写并且理解英文文档。

Be skilled at reading, writing and understanding of English documentation.