灯检工程师-高级工程师-Chengdu

1. 01

   生产活动管理（Production Activity Management） 参与车间的生产活动 Participate in the manufacture activities. 熟悉西林瓶及卡式瓶人工灯检、半自动灯检机及全自动灯检机等制剂生产的工作原理 Familiar with the working principle of manufacturing such as manual visual inspection, semi-automatic visual inspection machine and automatic visual inspection machine for vial and cartridge. 熟悉人工灯检、半自动灯检以及全自动灯检的相关标准操作规程 Familiar with the standard operating procedure of MVI, SAVI and AVI. 参与车间设备清洁 Participate in equipment cleaning in workshop. 参与工序文件升版 Revision of documents involved in process. 参与车间的验证活动 Participate in the validation activities. 了解制剂验证的基本概念，法规指南要求 Understand the basic validation concept and the

of regulation and guidance. 了解 cGMP法规要求 Understand the requirements of cGMP regulation.

2. 02

   文件管理（Document Management） 撰写GMP文件，如SOP、QRA等。 Draft GMP documentation, including SOPs, QRAs, and other quality-related documents. 检查、整理并审核生产记录及设备日志。 Review, compile, and verify production records and equipment logbooks. 撰写所属区域设备的用户需求说明书（URS） Prepare User Requirement Specifications (URS) for equipment within the responsible area.

3. 03

   质量事件管理（偏差/变更/CAPA/风险评估）Quality Event Management (Deviation / Change Control / CAPA / Risk Assessment) 起草并实施变更，调查偏差事件，撰写风险评估等 Initiate and implement change controls, investigate deviation events, and perform risk assessments. 跟踪偏差处理状态，组织相关讨论并推动偏差调查的进行及CAPA制定 Track deviation progress, coordinate cross-functional discussions, and drive deviation investigations and CAPA development to completion.

4. 04

   审计支持（Audit Support） 在审计期间协助现场协调工作 Provided on-site coordination support during regulatory and customer audits. 组织审计发现项的回复及相关跟进工作（如会议安排、问题跟踪等） Coordinated responses to audit observations and managed related follow-up activities, including meeting organization, issue tracking, and action item monitoring.

5. 05

   EHS职责（环境、健康与安全） 主导安全检查与审核，推动安全文化建设 Lead safety inspections and audits, and drive the development of a strong safety culture. 参与风险评估及事件调查工作 Participate in risk assessments and incident investigations.

6. 06

   人员培训与发展（Personnel Training & Development） 制定并组织GMP及EHS相关培训 Develop and deliver GMP and EHS training programs. 根据人员资质分配工作，跟踪培训完成情况 Assign tasks based on personnel qualifications and monitor training completion status.

7. 07

   其他工作（Other Tasks） 支持持续改进项目，提升生产效率 Support continuous improvement initiatives to enhance production efficiency. 任职要求（Requirements） 教育背景（Education） 药学、微生物学、生物工程、化学工程或相关专业本科及以上学历。 技能与胜任力（Skills & Competencies） 具备较强的问题解决能力和分析能力。 具备优秀的沟通协调能力。 工作细致严谨，组织能力强，具有团队合作精神。 专业技能（Technical Abilities） 熟练掌握文件编写及常用办公软件。 具备良好的文件管理能力，能够确保记录的准确性和完整性。 具备一定的英文听说读写能力，能够接待国内外客户现场参观及工艺介绍