岗位描述
1. 协助建立和完善专业的计算机系统验证和管理体系；
2. 协同专家实施计算机化系统首次验证和再验证项目；
3. 根据项目需求协助编写计算机化系统验证计划及验证方案、现场执行验证、编写报告；
4. 协同专家完成计算机系统相关SOP内容的制定和完善，确保符合行业法规；

5. 参与CSV相关的内外审计；
任职要求
1. 计算机，自动化，软件工、医药等相关专业本科以上学历；
2. 2-3年制药企业质量、工程或IT部门的相关工作经验，熟悉GMP环境下工作的基本要求；
3. 有计算机系统验证的实战经验，拥有以下一种或多种验证经验优先，如SAP，LIMS,WNS等；
4. 熟悉GMP法规，GAMP5对计算机系统验证和电子数据的要求，并能根据法规要求进行验证和维护数据库安全运行与故障处理，资源优化和容量规划能力 ；
5. 英语能力良好，尤其能熟练阅读和书写英语文件，口语较好者优先。


Reponsibilities:

Establishing and improving the csv and the management system to ensure the compliance of the computer system;Guiding the client the projects of computerized system validation and revalidation validation confirmation, organizing the establishment of computerized system validation plan to facilitate validation, and reviewing the validation scheme and conclusions for compliance;Organize and guide customers to complete the formulation and improvement of computer system content in SOP, and continuously promote the continuous improvement of GMP management system;Responsible for coordinating the implementation of the computer system validation program to ensure compliance with GMP related automated and/or csv;Responsible for the establishment of management procedures for csv;Participate the csv-related audits;Offer the csv-related trainnings;





Qualifications:


Bachelor degree or above in computer, automation, software engineering, medicine or related field;2-3 years related working experiences in pharmaceutical quality, engineering or IT department, familiar with basic requirements in GMP environment;Practical experiences in computer system verification, one or more of the following verification experiences is preferred, such as SAP,LIMS,WNS, etc;Familiar with GMP regulations, GAMP5 requirements on computer system verification and electronic data, and able to verify and preserve database safe operation fault handling, resource optimization with capacity planning according to regulations;Good command of English, especially good at reading and writing English documents, oral English is preferred.