第11篇 计算机系统管理岗位职责

岗位职责:

job responsibility:

1. 负责实验室单机版及网络版软件系统管理及维护,处理软件故障并记录;

in responsible of management and maintenance of analytical software that runs on single computer or networked computer system, troubleshooting the software problem and document the solution to the problem.

2. 负责实验室windows及软件系统访问权限管理、安全性管理及审计追踪管理;

in responsible of access control, security management and audit trail management of windows and software

3. 为实验室数据备份、归档及迁移提供支持;

provide support in data backup, archive and data migration.

4. 根据数据完整性及现有sop要求提供计算机系统生命周期管理;

provide computerized system life cycle management in accordance with data integrity requirement and established sops.

5. 撰写软件系统管理sop,并为软件系统用户提供日常操作相关的培训

establish software management sop, and provide daily operation trainings for end users.

6. 负责实验室计算机系统验证风险评估,验证方案制定及实施;调查处理验证过程中产生的偏差;负责验证报告撰写

in responsible of csv validation risk assessment, draft validation protocol, test script execution, deal with deviation during validation, and finish the validation report.

任职资格:

requirements:

1. 一年以上制药业信息化系统工作经验

minimum of 1 year experience with pharmaceutical

2. 熟悉lims,empower,科学数据管理系统(ecm 或 nugenesis)

familiar with lims, empower, scientific data management system (ecm or nugenesis)

3. 熟悉gamp5, cfr21 part 11等计算机系统验证相关的法规与指南;

familiar with regulatory requirements and guidance on computerized system, such as gamp5 and cfr21 part 11

4. 出色的沟通能力和执行力

excellent in communication and execution

5. 较强的英文读写能力

good in spoken and written communication in english

6. 具有生物制药、生命科学等专业背景本科及以上学历

bachelor’s degree and above in biochemical engineering, life science or related major.