系统运维专员(J13137)
上海药明康德新药开发有限公司
- 公司规模:10000人以上
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-08-11
- 工作地点:上海-浦东新区
- 招聘人数:1人
- 工作经验:无工作经验
- 学历要求:招1人
- 语言要求:不限
- 职位月薪:0.8-2万/月
- 职位类别:系统工程师 技术支持/维护工程师
职位描述
工作职责:
1. Responsible for the operation and maintenance of the business system, to ensure the daily stable operation of the on-line system, including the maintenance of authority, account management, handling of system abnormalities, daily software inspection and regular hardware patrol inspection; Ensure that the retired system can handle the removal process of software and hardware in accordance with the regulation of the company and department.
负责业务系统的运维,确保上线系统的日常稳定运行,其中包括权限的维护,账号管理,系统异常的处理,日常的软件检查以及定期的硬件巡检;确保退役系统能够按照公司及部门规定进行软硬件的下架流程处理。
2. Ensure that GxP related system validation complies with regulations to meet data reliability requirements; Ensure that GxP-related systems remain validated throughout the life cycle.
确保GxP相关的系统验证符合法规以达到数据可靠性的要求;确保GxP相关的系统其整个生命周期保持验证状态。
3. As a system operation and maintenance specialist, he/she can effectively communicate and coordinate with end users, IT departments, suppliers and other resources, solve problems effectively and timely, and ensure the business running smoothly.
作为系统运维专员,能够有效的与业务部门终端用户、IT部门以及供应商等资源进行沟通协调,有效并及时的解决问题,确保业务的正常运营。
4. Support external customer audits and internal audits.
支持外部客户审计和内部审计。
任职资格:
1. College degree or above in Computer Sciences or equivalent;
计算机科学或相关专业大专以上学位;
2. At least 3 years of experience in system operation and maintenance, preferably with computerized system validation experience in the pharmaceutical industry;
至少3年系统运维的经验,有医药行业计算机化系统验证经验者优先;
3. A certain knowledge and expertise in regulations like China GMP computerized system appendix, Medicine Data Management Practice Exposure Draft, 21 CFR Part 11, EU GMP Annex 11, GAMP 5, OECD GLP Principle No.17 and ICH Q9/Q10;
对于中国GMP计算机化系统附录,药品数据管理规范征求意见稿,21 CFR Part11,欧盟GMP附录11,GAMP5,OECD GLP 17号法规及质量风险管理有一定理解;
4. A certain knowledge of IT systems in pharmaceutical industries, including Data Management Systems(such as NBU), LIMS, Manufacturing Execution System, and others;
对于制药行业的IT系统,包括数据管理系统(例如NBU),LIMS,制造执行系统或其他的IT系统有一定的认识及了解;
5. Good communication skill & mature interpersonal skills
有较好的沟通技巧和人际交往能力
职能类别: 系统工程师 技术支持/维护工程师
公司介绍
联系方式
- Email:zhuyun@wuxiapptec.com
- 公司地址:江北新区华康路122号南京生物医药谷加速器四期07栋
- 电话:15738851478