中国僵尸片,亚洲欧美国产另类视频,亚洲精品无码人妻无码,亚洲有码转帖,亚洲欧美精品伊人久久,97精品依人久久久

Job Responsibilities 工作職責(zé)：
1.Maintaining CSV policies and procedures to align with GAMP, PDA and PIC/S guidance;
維護計算機系統(tǒng)驗證（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)程驗證計算機系統(tǒng)；
3.Providing guidance for validation activities of computer systems to functional SMEs;
為功能性SME提供計算機系統(tǒng)驗證活動指導(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)項目中代表CSV鄰導(dǎo)，確保GMP項目實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）、實驗室信息管理系統(tǒng)（LIMS）、色譜數(shù)據(jù)系統(tǒng)（CDS）、計算機維護管理系統(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，例如驗證計劃、URS、規(guī)范、測試方案和報告、驗證總結(jié)報告和相關(guān)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(tǒng)驗證的普遍認識和流程方面的培訓(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，確保對其受監(jiān)管的計算機系統(tǒng)進行檢查，并對計算機系統(tǒng)進行內(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)有的計算機系統(tǒng)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(xiàn)有業(yè)務(wù)系統(tǒng)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(yè)務(wù)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(lǐng)導(dǎo)跨職能團隊建議持續(xù)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(lǐng)導(dǎo)IT系統(tǒng)項目，并確保它們滿足業(yè)務(wù)需求，成本和進度。系統(tǒng)包括企業(yè)資源計劃（ERP），實驗室信息管理系統(tǒng)（LIMS），色譜數(shù)據(jù)系統(tǒng)（CDS），計算機維護管理系統(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，選擇和管理供應(yīng)商以提供技術(shù)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(yè)“***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(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項目以及運營SOP的文檔。
19.Conducting training for the computer systems.
對計算機系統(tǒng)進行培訓(xùn)。
20.Representing as the IT Application Subject Matter Expert during the regulatory and financial audits.
在法規(guī)和財務(wù)審計中代表IT業(yè)務(wù)系統(tǒng)專家。
21.Other work arranged by superior leaders.
上級領(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，計算機科學(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或驗證正規(guī)工作經(jīng)驗或制藥或醫(yī)療器械行業(yè)工作經(jīng)驗者優(yōu)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(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。