Job Responsibilities 工作職責：
1.Maintaining CSV policies and procedures to align with GAMP, PDA and PIC/S guidance;
維護計算機系統驗證（CSV）政策和規程，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;
與GMP職能部門協作，確保按照CSV政策與規程驗證計算機系統；
3.Providing guidance for validation activities of computer systems to functional SMEs;
為功能性SME提供計算機系統驗證活動指導；
4.Representing as the CSV Subject Matter Expert during the regulatory audits;
在常規審核期間代表CSV領域專家；
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系統項目中代表CSV鄰導，確保GMP項目實施和可交付成果符合CSV政策和規程。GMP系統包括企業資源規劃（ERP）、實驗室信息管理系統（LIMS）、色譜數據系統（CDS）、計算機維護管理系統（CMMS）、學習管理系統（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;
編制和審核CSV文檔，例如驗證計劃、URS、規范、測試方案和報告、驗證總結報告和相關SOP、偏差和變更控制與評估；
7.Conducting training for the computer systems validation general awareness and processes;
進行計算機系統驗證的普遍認識和流程方面的培訓；
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;
與GMP職能部門協作，確保對其受監管的計算機系統進行檢查，并對計算機系統進行內部審核，以確保它們符合要求；
9.Working with vendors to ensure their deliverables complies with policies and procedures;
與供應商協作，確保他們的可交付成果符合政策和規程；
10.Supporting the existing computer systems periodic reviews and remediation activities;
支持現有的計算機系統定期檢查和補救活動；
11.Supporting CSV activities for existing business systems operational activities inclusive of CAPA, deviations, changes and upgrades.
支持現有業務系統運營活動的CSV活動，包括CAPA、偏差、變更和升級；
12.Collaborating with various functions to identify the business needs and identify and implement solutions to meet the requirement.
與各職能部門共同建議業務需求，并確定和實施滿足各部門要求的解決方案。
13.Leading cross-functional teams to identify continuous improvements and implement them.
領導跨職能團隊建議持續改進并實施。
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.
領導IT系統項目，并確保它們滿足業務需求，成本和進度。系統包括企業資源計劃（ERP），實驗室信息管理系統（LIMS），色譜數據系統（CDS），計算機維護管理系統（CMMS），傳感器監控系統 (CMS), 企業質量管理系統（EQMS）等。
15.Sourcing, selecting and managing the vendors to provide the technical solutions and consultancy implementation support.
采購，選擇和管理供應商以提供技術解決方案和顧問實施支持。
16.Identifying and implementing industry ‘Best Practices’ for the IT solutions, processes and controls.
建議和實施針對IT解決方案，流程和控制的行業“***實踐”。
17.Supporting and maintaining the existing business systems inclusive of changes and upgrades.
支持和維護包括更改和升級在內的現有業務系統。
18.Delivering documentation for the IT projects and operational SOPs.
交付有關IT項目以及運營SOP的文檔。
19.Conducting training for the computer systems.
對計算機系統進行培訓。
20.Representing as the IT Application Subject Matter Expert during the regulatory and financial audits.
在法規和財務審計中代表IT業務系統專家。
21.Other work arranged by superior leaders.
上級領導安排的其他工作。
22.Comply with the company's information security management related system and requirements.
遵守公司關于信息安全管理的相關制度和要求。
Qualification 任職資格：
1.Bachelor’s Degree in Computer Science, Engineering, Pharmaceutical Sciences, or a related scientific discipline required.
本科及以上學歷，計算機科學、工程、制藥科學或相關專業。
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.
具備五年CSV或驗證正規工作經驗或制藥或醫療器械行業工作經驗者優先考慮。
3.The ability to effectively prioritize and manage multiple project workloads;
具備同時安排多個項目工作內容并按照優先順序高效管理；
4.Good communication skills and teamwork skills.
具備良好的溝通能力和團隊合作能力。
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（閱讀、寫作、口語），能夠與其他部門進行順暢交流。