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Job Responsibilities 工作職責(zé)：
1.Maintaining CSV policies and procedures to align with GAMP, PDA and PIC/S guidance;
維護(hù)計(jì)算機(jī)系統(tǒng)驗(yàn)證（CSV）政策和規(guī)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(xié)作，確保按照CSV政策與規(guī)程驗(yàn)證計(jì)算機(jī)系統(tǒng)；
3.Providing guidance for validation activities of computer systems to functional SMEs;
為功能性SME提供計(jì)算機(jī)系統(tǒng)驗(yàn)證活動(dòng)指導(dǎo)；
4.Representing as the CSV Subject Matter Expert during the regulatory audits;
在常規(guī)審核期間代表CSV領(lǐng)域?qū)＜遥?br>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(tǒng)項(xiàng)目中代表CSV鄰導(dǎo)，確保GMP項(xiàng)目實(shí)施和可交付成果符合CSV政策和規(guī)程。GMP系統(tǒng)包括企業(yè)資源規(guī)劃（ERP）、實(shí)驗(yàn)室信息管理系統(tǒng)（LIMS）、色譜數(shù)據(jù)系統(tǒng)（CDS）、計(jì)算機(jī)維護(hù)管理系統(tǒng)（CMMS）、學(xué)習(xí)管理系統(tǒng)（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(yàn)證計(jì)劃、URS、規(guī)范、測(cè)試方案和報(bào)告、驗(yàn)證總結(jié)報(bào)告和相關(guān)SOP、偏差和變更控制與評(píng)估；
7.Conducting training for the computer systems validation general awareness and processes;
進(jìn)行計(jì)算機(jī)系統(tǒng)驗(yàn)證的普遍認(rèn)識(shí)和流程方面的培訓(xùn)；
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(xié)作，確保對(duì)其受監(jiān)管的計(jì)算機(jī)系統(tǒng)進(jìn)行檢查，并對(duì)計(jì)算機(jī)系統(tǒng)進(jìn)行內(nèi)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(yīng)商協(xié)作，確保他們的可交付成果符合政策和規(guī)程；
10.Supporting the existing computer systems periodic reviews and remediation activities;
支持現(xiàn)有的計(jì)算機(jī)系統(tǒng)定期檢查和補(bǔ)救活動(dòng)；
11.Supporting CSV activities for existing business systems operational activities inclusive of CAPA, deviations, changes and upgrades.
支持現(xiàn)有業(yè)務(wù)系統(tǒng)運(yùn)營(yíng)活動(dòng)的CSV活動(dòng)，包括CAPA、偏差、變更和升級(jí)；
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(yè)務(wù)需求，并確定和實(shí)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(lǐng)導(dǎo)跨職能團(tuán)隊(duì)建議持續(xù)改進(jìn)并實(shí)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(lǐng)導(dǎo)IT系統(tǒng)項(xiàng)目，并確保它們滿足業(yè)務(wù)需求，成本和進(jìn)度。系統(tǒng)包括企業(yè)資源計(jì)劃（ERP），實(shí)驗(yàn)室信息管理系統(tǒng)（LIMS），色譜數(shù)據(jù)系統(tǒng)（CDS），計(jì)算機(jī)維護(hù)管理系統(tǒng)（CMMS），傳感器監(jiān)控系統(tǒng) (CMS), 企業(yè)質(zhì)量管理系統(tǒng)（EQMS）等。
15.Sourcing, selecting and managing the vendors to provide the technical solutions and consultancy implementation support.
采購(gòu)，選擇和管理供應(yīng)商以提供技術(shù)解決方案和顧問(wèn)實(shí)施支持。
16.Identifying and implementing industry ‘Best Practices’ for the IT solutions, processes and controls.
建議和實(shí)施針對(duì)IT解決方案，流程和控制的行業(yè)“***實(shí)踐”。
17.Supporting and maintaining the existing business systems inclusive of changes and upgrades.
支持和維護(hù)包括更改和升級(jí)在內(nèi)的現(xiàn)有業(yè)務(wù)系統(tǒng)。
18.Delivering documentation for the IT projects and operational SOPs.
交付有關(guān)IT項(xiàng)目以及運(yùn)營(yíng)SOP的文檔。
19.Conducting training for the computer systems.
對(duì)計(jì)算機(jī)系統(tǒng)進(jìn)行培訓(xùn)。
20.Representing as the IT Application Subject Matter Expert during the regulatory and financial audits.
在法規(guī)和財(cái)務(wù)審計(jì)中代表IT業(yè)務(wù)系統(tǒng)專家。
21.Other work arranged by superior leaders.
上級(jí)領(lǐng)導(dǎo)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(guān)于信息安全管理的相關(guān)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(xué)歷，計(jì)算機(jī)科學(xué)、工程、制藥科學(xué)或相關(guān)專業(yè)。
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(yàn)證正規(guī)工作經(jīng)驗(yàn)或制藥或醫(yī)療器械行業(yè)工作經(jīng)驗(yàn)者優(yōu)先考慮。
3.The ability to effectively prioritize and manage multiple project workloads;
具備同時(shí)安排多個(gè)項(xiàng)目工作內(nèi)容并按照優(yōu)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(tuán)隊(duì)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(xiě)作、口語(yǔ)），能夠與其他部門進(jìn)行順暢交流。