南京招聘

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

药明康德是国际领先的开放式能力与技术平台公司，为全球制药及医疗器械等领域提供从药物发现、开发到市场化的全方位一体化的实验室研发和生产服务。本着以研究为首任，以客户为中心的宗旨，药明康德通过高性价比、高效率的服务平台帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。药明康德平台涵括化学药研发和生产、细胞及基因疗法研发生产、药物研发和医疗器械测试等，正承载着来自全球30多个国家的3500多家创新合作伙伴的数千个研发创新项目，致力于将最新和***的医药和健康产品带给全球病患，实现“让天下没有难做的药，难治的病”的梦想。