Job Responsibilities 工作职责：
1.Maintaining CSV policies and procedures to align with GAMP, PDA and PIC/S guidance;
维护计算机系统验证（CSV）政策和规程，使之符合GAMP、PDA和PIC/S指南；
2.Collaborating with GMP functional departments to ensuring the computer systems are validated in accordance with CSV policies and procedures;
与GMP职能部门协作，确保按照CSV政策与规程验证计算机系统；
3.Providing guidance for validation activities of computer systems to functional SMEs;
为功能性SME提供计算机系统验证活动指导；
4.Representing as the CSV Subject Matter Expert during the regulatory audits;
在常规审核期间代表CSV领域专家；
5.Representing as the CSV lead in the IT GMP systems projects to ensuring that the GMP projects implementation and deliverables meeting CSV policies and procedures. GMP systems include Enterprise Resource Planning (ERP), Laboratory Information Management System (LIMS), Chromatography Data System (CDS), Computerized Maintenance Management System (CMMS), Learning Management System (LMS) etc.
在IT GMP系统项目中代表CSV邻导，确保GMP项目实施和可交付成果符合CSV政策和规程。GMP系统包括企业资源规划（ERP）、实验室信息管理系统（LIMS）、色谱数据系统（CDS）、计算机维护管理系统（CMMS）、学习管理系统（LMS）等；
6.Preparing and reviewing of CSV documents e.g. validation plan, URS, specifications, testing protocols and reports and validation summary report and associated SOPs, deviations and change controls and assessments;
编制和审核CSV文档，例如验证计划、URS、规范、测试方案和报告、验证总结报告和相关SOP、偏差和变更控制与评估；
7.Conducting training for the computer systems validation general awareness and processes;
进行计算机系统验证的普遍认识和流程方面的培训；
8.Working with GMP functions to ensure they are inspection ready for their regulated computer systems and conducting internal audits on the computer systems to ensure compliance;
与GMP职能部门协作，确保对其受监管的计算机系统进行检查，并对计算机系统进行内部审核，以确保它们符合要求；
9.Working with vendors to ensure their deliverables complies with policies and procedures;
与供应商协作，确保他们的可交付成果符合政策和规程；
10.Supporting the existing computer systems periodic reviews and remediation activities;
支持现有的计算机系统定期检查和补救活动；
11.Supporting CSV activities for existing business systems operational activities inclusive of CAPA, deviations, changes and upgrades.
支持现有业务系统运营活动的CSV活动，包括CAPA、偏差、变更和升级；
12.Collaborating with various functions to identify the business needs and identify and implement solutions to meet the requirement.
与各职能部门共同建议业务需求，并确定和实施满足各部门要求的解决方案。
13.Leading cross-functional teams to identify continuous improvements and implement them.
领导跨职能团队建议持续改进并实施。
14.Leading the IT systems projects and ensuring that they meet the business requirements, cost and schedule. Systems include Enterprise Resource Planning (ERP), Laboratory Information Management System (LIMS), Chromatography Data System (CDS), Computerized Maintenance Management System (CMMS), Sensors Monitoring System (CMS), Enterprise Quality Management System (EQMS) etc.
领导IT系统项目，并确保它们满足业务需求，成本和进度。系统包括企业资源计划（ERP），实验室信息管理系统（LIMS），色谱数据系统（CDS），计算机维护管理系统（CMMS），传感器监控系统 (CMS), 企业质量管理系统（EQMS）等。
15.Sourcing, selecting and managing the vendors to provide the technical solutions and consultancy implementation support.
采购，选择和管理供应商以提供技术解决方案和顾问实施支持。
16.Identifying and implementing industry ‘Best Practices’ for the IT solutions, processes and controls.
建议和实施针对IT解决方案，流程和控制的行业“***实践”。
17.Supporting and maintaining the existing business systems inclusive of changes and upgrades.
支持和维护包括更改和升级在内的现有业务系统。
18.Delivering documentation for the IT projects and operational SOPs.
交付有关IT项目以及运营SOP的文档。
19.Conducting training for the computer systems.
对计算机系统进行培训。
20.Representing as the IT Application Subject Matter Expert during the regulatory and financial audits.
在法规和财务审计中代表IT业务系统专家。
21.Other work arranged by superior leaders.
上级领导安排的其他工作。
22.Comply with the company's information security management related system and requirements.
遵守公司关于信息安全管理的相关制度和要求。
Qualification 任职资格：
1.Bachelor’s Degree in Computer Science, Engineering, Pharmaceutical Sciences, or a related scientific discipline required.
本科及以上学历，计算机科学、工程、制药科学或相关专业。
2. 5 years’ CSV or validation working experience in a regulated environment. Working experience in the pharmaceutical or medical device industries is an added advantage.
具备五年CSV或验证正规工作经验或制药或医疗器械行业工作经验者优先考虑。
3.The ability to effectively prioritize and manage multiple project workloads;
具备同时安排多个项目工作内容并按照优先顺序高效管理；
4.Good communication skills and teamwork skills.
具备良好的沟通能力和团队合作能力。
5.Good communication skills in Chinese and English (reading, writing, speaking), able to communicating smoothly with other departments.
良好的中英文交流能力（阅读、写作、口语），能够与其他部门进行顺畅交流。