Lab IT（实验室验证 外资知名药企）

·
计算机系统质量标准
Computer
System Quality

ü 负责分析设备的计算机系统验证工作，撰写验证文件，起草系统管理操作规程，确保系统的验证符合法规和礼来质量要求。
Responsible
for the validation of the analytical equipment’s computer system, prepare the
validation documents,
draft system administration working
instruction, ensure that the
system
validation activities complied with regulatory requirement and Lilly quality
requirement.

ü 与供应商和业务部门协作完成计算机系统软件验证或升级
Cooperate
with suppliers and business to complete the software validation or upgrade of
computer
system.

ü 熟悉实验室计算机系统的基础架构，了解系统功能，解决用户的现场问题并提供IT技术支持
Familiar
with laboratory computer system’s architecture and the system functions,
on-site
troubleshooting
for the problem and provide IT technical support.

ü 完成系统变更评估，建立新系统信息，既有文件更新
Complete system change evaluation, establish new
system information, update existing documents.

ü 参与到IT或业务部门的项目中，有效地实施IT解决方案。
Involved in IT & business project to implement
IT solutions effectively.


·
业务支持/客户管理
Business
Support/ Customer Management

ü 理解所属区域的业务流程，理解IT解决方案对于业务部门的益处。
Understand
business process of the assigned area, understand how IT solution can bring
benefit to business.

ü 与服务的业务人员工作紧密切合，建立友好的工作关系。
Works
closely with the personnel in the business area and builds working
relationships.

ü
团队成员之间分享知识和经验，实现跨业务区域支持。
Knowledge and
experience share within team, make cross business area support come true.

·
安全和质量
Safety
and Quality
ü 遵守HSE各项管理流程，履行安全生产职责要求。
Follow
various HSE management procedures and fulfill the work safety responsibilities.

ü 具有高度的GMP和数据可靠性意识，确保验证交付内容规范、准确，符合合规要求
Strong GMP and data integrity awareness to ensure
validation deliverables are accurate, well- documented, and compliant.