- 目錄
第1篇 qc驗證主管崗位職責任職要求
qc驗證主管崗位職責
job summary:
ensure the maintenance and qualification of the analytical and metrological equipment of the novacyl quality control laboratory;
support non-routine analytic activities such as analytical validation， analytical transfers and method troubleshooting;
manage the analysts in charge of qualification and validation activities (resources from the hplc and physical chemistry laboratory seconded to the qualification/validation projects).
mains missions :
maintenance/qualification of laboratory equipment ;
management of analytical transfer and validations.
mission 1: maintenance
organizes the preventive maintenance (internal or e_ternal) and the periodic verifications (internal or e_ternal) of the equipment of the laboratory (planning / follow-up of the supplier) in the respect of the deadlines and costs
organizes the curative maintenance of laboratory equipment during breakdowns (internal or e_ternal) (planning / monitoring of service providers)
manages stocks of spare parts needed for first-level maintenance
represents the maintenance pole during audits and inspections by the authorities
supports laboratory technicians in case of equipment problems
organizes calibration/verification of standards dedicated to equipment verification by e_ternal agencies
mission 2: qualification laboratory equipment
write the equipment qualification documentation for the laboratory (urs， protocols ....)
organize qualification by suppliers
conduct and / or organize additional tests not performed by suppliers (internal or outsourced)
write the equipment usage documentation (operating modes， logbooks ...)
presents qualification records during audits and inspections by the authorities
ensures the training of technicians in the use of equipment
organizes equipment supplier qualification
participates in the choice of laboratory equipment and software
mission 3: coordination of analytical transfer， validations and troubleshooting activities
supports the technicians in case of analytical problem， technical oos， technical question write the study protocols/report for the laboratory off stream activities (analytical validation， transfer ...) organise with the laboratory staff the studies for off stream activities (analytical validation， transfer ...)
participates in the creation / modification of the working documentation (analytical methods， work instructions…
mission 4: laboratory life
participates to various meetings related to the operation of the service (daily， monthly ...) leads actions to improve the operation of the maintenance center and the laboratory. defines with the manager the investment strategy for laboratory equipment is the system administrator of the lab's si
required skills:
1. bachelor degree in relevant;
2. with 5-10 years professional e_perience in a quality control laboratory in a gmp environment;
3. spoken english is a plus;
4. good knowledge of the standards applicable to the laboratory (pharmacopoeia， .ich...);
5. good understanding of equipment and analytical laboratory techniques (titration， gc， hplc， spectroscopy， karl fischer， ....);
6. knowledge of software related to laboratory equipment.
qc驗證主管崗位
第2篇 驗證主管崗位職責
驗證主管 安禮特(上海)醫(yī)藥科技有限公司 安禮特(上海)醫(yī)藥科技有限公司,安禮特 五、驗證主管1-2人
崗位職責
1、參與生產系統(tǒng)驗證,計算機化系統(tǒng)驗證項目實施
2、制定驗證總計劃/風險評估/設計文件/驗證文件/驗證報告/追溯矩陣文件
3、參與驗證過程中的偏差、變更處理。
崗位要求:
1、具有藥學相關專業(yè)本科以上學歷;
2、有參與建立驗證體系的經驗。
3、制定過gmp驗證總計劃和驗證實施計劃。
4、有固體制劑設備、公用系統(tǒng)確認經驗
5、熟悉驗證過的主要設備原理。
6、懂計算機化系統(tǒng)驗證者優(yōu)先
7、具有基礎的制藥裝備自動化、應用軟件基礎知識。
第3篇 控制系統(tǒng)集成驗證崗主管工程師崗位職責描述崗位要求
職位描述：
職責描述：
'1.負責實施控制系統(tǒng)硬件在回路、半物理等系統(tǒng)的集成與驗證試驗工作，以及相應的技術文件編制。
2.參與控制系統(tǒng)硬件在回路、半物理等控制系統(tǒng)總體相關集成驗證平臺的建設及協(xié)調，以及相應技術文件編制工作。
3.參與控制系統(tǒng)集成驗證專業(yè)相關流程、工具、標準、規(guī)范和數(shù)據庫等工作
4.參與組織制定控制系統(tǒng)集成驗證的技術發(fā)展路線，以及基礎技術研究'
職位要求：
'1.控制系統(tǒng)總體或控制系統(tǒng)試驗設計師任職5年（碩士研究生3年，博士研究生2年）及以上，具有caac/faa適航認證相關經驗或知識者優(yōu)先。
2.掌握控制系統(tǒng)設計、控制系統(tǒng)試驗基本流程和方法；
3.能熟練閱讀本專業(yè)英文資料，能用英語撰寫技術報告或技術論文，有一定的英語口語交流能力，能較好地理解英文技術講座和報告；
4.熟練掌握matlab/simulink、c/c++、labview等控制系統(tǒng)建模與仿真軟件以及控制系統(tǒng)試驗技術。'
第4篇 產品驗證主管崗位職責
實驗室主管+產品驗證 美埃(中國)環(huán)境凈化有限公司 中山美埃凈化技術有限公司，美埃職責描述:
1、 新開發(fā)、改進產品的性能、可靠性的實驗驗證和評價;
2、 針對售后問題進行產品、關鍵元器件市場投訴問題分析;
3、 產品新引進風機、電路板等關鍵資材對整機系統(tǒng)的影響評估和實驗驗證;
4、 協(xié)助及跟進完善整機整改流程;
5、 根據市場及售后問題完善評價體系、標準制度、體系建設;1、 新開發(fā)、改進產品的性能、可靠性的實驗驗證和評價;
6、全面管理實驗室的日常工作，合理安排及協(xié)調好日常測試任務;
7、熟悉實驗室測試儀器和裝置，對實驗結果進行分析，解釋;
8、熟悉專業(yè)領域內各類測試標準、產品標準，熟悉各類樣品處理方法和測試分析方法，開發(fā)新測試方法;
9、對實驗室人員進行有效管理，并協(xié)調好各部門間的關系，使工作順暢進行;對實驗室人員的技術水平提高進行培訓和考核;
任職要求:
1、本科以上，機電、暖通或相近專業(yè);環(huán)境工程、化學分析類相關專業(yè)
2、具備相關專業(yè)產品評價3年以上工作經驗;
3、熟練操作電腦、office、autocad等繪圖軟件;
4、有家電行業(yè)工作經驗者優(yōu)先考慮;
5、了解第三方測試;
有cnas實驗室認證經驗，有環(huán)境、空氣凈化產品測試經驗者優(yōu)先。
第5篇 整機集成及驗證主管工程師崗位職責描述崗位要求
職位描述：
職責描述：
1. 協(xié)助開展發(fā)動機研制需求分析、總要求的編制
2. 協(xié)助開展發(fā)動機研制型號規(guī)范的編制
3. 協(xié)助開展發(fā)動機驗證計劃的編制
4. 協(xié)助開展設計過程、與飛機集成等過程的飛/發(fā)技術協(xié)調
5. 協(xié)助開展試驗總體策劃與試驗安排，試驗方案制定等試驗總體相關工作
6. 協(xié)助開展試驗實施過程中的技術協(xié)調和試驗數(shù)據管理
7. 協(xié)助開展發(fā)動機設計需求管理
8. 協(xié)助開展本專業(yè)設計體系建設
職位要求：
1. 總體設計設計師任職3年以上，有總體設計、系統(tǒng)工程工作經驗。
2. 航空宇航推進專業(yè)、航空發(fā)動機專業(yè)等
3. 全日制大學本科及以上學歷
4. 具備航空發(fā)動機專業(yè)知識、系統(tǒng)工程專業(yè)知識
5. 具有中級（工程師）職稱以上者優(yōu)先
6. 能熟練閱讀本專業(yè)英文資料，能用英語撰寫技術報告或技術論文，有一定的英語口語交流能力，能較好地理解英文技術講座和報告
第6篇 qc驗證主管崗位職責
qc validation/qualification supervisor儀器驗證主管 諾化仕(無錫)制藥有限公司 諾化仕(無錫)制藥有限公司,諾化仕,諾化仕 job summary:
?ensure the maintenance and qualification of the analytical and metrological equipment of the novacyl quality control laboratory;
?support non-routine analytic activities such as analytical validation, analytical transfers and method troubleshooting;
?manage the analysts in charge of qualification and validation activities (resources from the hplc and physical chemistry laboratory seconded to the qualification/validation projects).
mains missions :
?maintenance/qualification of laboratory equipment ;
?management of analytical transfer and validations.
mission 1: maintenance
organizes the preventive maintenance (internal or e_ternal) and the periodic verifications (internal or e_ternal) of the equipment of the laboratory (planning / follow-up of the supplier) in the respect of the deadlines and costs
organizes the curative maintenance of laboratory equipment during breakdowns (internal or e_ternal) (planning / monitoring of service providers)
manages stocks of spare parts needed for first-level maintenance
represents the maintenance pole during audits and inspections by the authorities
supports laboratory technicians in case of equipment problems
organizes calibration/verification of standards dedicated to equipment verification by e_ternal agencies
mission 2: qualification laboratory equipment
write the equipment qualification documentation for the laboratory (urs, protocols ....)
organize qualification by suppliers
conduct and / or organize additional tests not performed by suppliers (internal or outsourced)
write the equipment usage documentation (operating modes, logbooks ...)
presents qualification records during audits and inspections by the authorities
ensures the training of technicians in the use of equipment
organizes equipment supplier qualification
participates in the choice of laboratory equipment and software
mission 3: coordination of analytical transfer, validations and troubleshooting activities
supports the technicians in case of analytical problem, technical oos, technical question write the study protocols/report for the laboratory off stream activities (analytical validation, transfer ...) organise with the laboratory staff the studies for off stream activities (analytical validation, transfer ...)
participates in the creation / modification of the working documentation (analytical methods, work instructions…
mission 4: laboratory life
participates to various meetings related to the operation of the service (daily, monthly ...) leads actions to improve the operation of the maintenance center and the laboratory. defines with the manager the investment strategy for laboratory equipment is the system administrator of the lab's si
required skills:
1. bachelor degree in relevant;
2. with 5-10 years professional e_perience in a quality control laboratory in a gmp environment;
3. spoken english is a plus;
4. good knowledge of the standards applicable to the laboratory (pharmacopoeia, .ich...);
5. good understanding of equipment and analytical laboratory techniques (titration, gc, hplc, spectroscopy, karl fischer, ....);
6. knowledge of software related to laboratory equipment.
