HZLJ- QA Alarm Review and PRE Review

最低任职要求Minimum Requirement:

1. 本科及以上学历，自动化、控制工程、机电一体化、计算机、制药工程、生物工程或相关专业优先。

Bachelor’s degree or above; a major related to automation, control engineering, computer science, pharmaceutical engineering, or bioengineering is preferred.

2. 具备制药、生物制药或其他受监管行业的自动化设备/系统相关经验；具有GMP环境工作经验者优先。

Experience with automated equipment or systems in pharmaceutical, biopharmaceutical, or another regulated industry; GMP experience is preferred.

3. 熟悉自动化设备和系统，并熟悉至少一种药企自动化设备/系统的自动化原理、控制逻辑和流程，如DCS/DeltaV、SCADA、EMS/BMS、PLC、LIMS或其他生产/实验室自动化系统。

Familiar with automated equipment and systems, including the automation principles, control logic, and process flow of at least one pharmaceutical automation system, such as DCS/DeltaV, SCADA, EMS/BMS, PLC, LIMS, or another manufacturing/laboratory automation system.

4. 熟悉自动化或报警信息的全流程，包括报警产生、识别、通知、响应、确认、记录、影响评估、偏差升级、周期回顾、趋势分析和持续改进。

Familiar with the end-to-end lifecycle of automation or alarm information, including generation, identification, notification, response, acknowledgement, documentation, impact assessment, deviation escalation, periodic review, trending, and continuous improvement.

其他要求Other Requirements:

1. 具备基本GMP意识；熟悉GAMP 5和21 CFR Part 11者优先。

Basic GMP awareness; knowledge of GAMP 5 and 21 CFR Part 11 is preferred.

2. 逻辑性强，能够基于事实、数据和风险识别问题、梳理流程并形成清晰结论。

Strong logical thinking and the ability to identify issues, map processes, and form clear conclusions based on facts, data, and risk.

3. 具备较强的跨部门沟通与表达能力，能够与生产、工程、自动化、验证、QC、IT及QA有效协作。

Strong cross-functional communication skills and ability to collaborate with Manufacturing, Engineering, Automation, Validation, QC, IT, and QA.

4. 具备良好的非职级领导力和影响力，能够推动问题闭环、协调资源并促进要求落地。

Demonstrated leadership and influence without formal authority, including driving issue closure, coordinating resources, and facilitating implementation.

5. 具备良好的中英文文件阅读和书面表达能力。

Good Chinese and English reading and writing skills.