- 目錄
第1篇 qc驗證主管崗位職責(zé)任職要求
qc驗證主管崗位職責(zé)
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(zé)
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(zé)
1、參與生產(chǎn)系統(tǒng)驗證,計算機(jī)化系統(tǒng)驗證項目實施
2、制定驗證總計劃/風(fēng)險評估/設(shè)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(xué)相關(guān)專業(yè)本科以上學(xué)歷;
2、有參與建立驗證體系的經(jīng)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(shè)備、公用系統(tǒng)確認(rèn)經(jīng)驗
5、熟悉驗證過的主要設(shè)備原理。
6、懂計算機(jī)化系統(tǒng)驗證者優(yōu)先
7、具有基礎(chǔ)的制藥裝備自動化、應(yīng)用軟件基礎(chǔ)知識。
第3篇 控制系統(tǒng)集成驗證崗主管工程師崗位職責(zé)描述崗位要求
職位描述：
職責(zé)描述：
'1.負(fù)責(zé)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(yīng)的技術(shù)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(guān)集成驗證平臺的建設(shè)及協(xié)調(diào)，以及相應(yīng)技術(shù)文件編制工作。
3.參與控制系統(tǒng)集成驗證專業(yè)相關(guān)流程、工具、標(biāo)準(zhǔn)、規(guī)范和數(shù)據(jù)庫等工作
4.參與組織制定控制系統(tǒng)集成驗證的技術(shù)發(fā)展路線，以及基礎(chǔ)技術(shù)研究'
職位要求：
'1.控制系統(tǒng)總體或控制系統(tǒng)試驗設(shè)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(rèn)證相關(guān)經(jīng)驗或知識者優(yōu)先。
2.掌握控制系統(tǒng)設(shè)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(shù)報告或技術(shù)論文，有一定的英語口語交流能力，能較好地理解英文技術(shù)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(shù)。'
第4篇 產(chǎn)品驗證主管崗位職責(zé)
實驗室主管+產(chǎn)品驗證 美埃(中國)環(huán)境凈化有限公司 中山美埃凈化技術(shù)有限公司，美埃職責(zé)描述:
1、 新開發(fā)、改進(jìn)產(chǎn)品的性能、可靠性的實驗驗證和評價;
2、 針對售后問題進(jìn)行產(chǎn)品、關(guān)鍵元器件市場投訴問題分析;
3、 產(chǎn)品新引進(jìn)風(fēng)機(jī)、電路板等關(guān)鍵資材對整機(jī)系統(tǒng)的影響評估和實驗驗證;
4、 協(xié)助及跟進(jìn)完善整機(jī)整改流程;
5、 根據(jù)市場及售后問題完善評價體系、標(biāo)準(zhǔn)制度、體系建設(shè);1、 新開發(fā)、改進(jìn)產(chǎn)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(diào)好日常測試任務(wù);
7、熟悉實驗室測試儀器和裝置，對實驗結(jié)果進(jìn)行分析，解釋;
8、熟悉專業(yè)領(lǐng)域內(nèi)各類測試標(biāo)準(zhǔn)、產(chǎn)品標(biāo)準(zhǔn)，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(jìn)行有效管理，并協(xié)調(diào)好各部門間的關(guān)系，使工作順暢進(jìn)行;對實驗室人員的技術(shù)水平提高進(jìn)行培訓(xùn)和考核;
任職要求:
1、本科以上，機(jī)電、暖通或相近專業(yè);環(huán)境工程、化學(xué)分析類相關(guān)專業(yè)
2、具備相關(guān)專業(yè)產(chǎn)品評價3年以上工作經(jīng)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(jīng)驗者優(yōu)先考慮;
5、了解第三方測試;
有cnas實驗室認(rèn)證經(jīng)驗，有環(huán)境、空氣凈化產(chǎn)品測試經(jīng)驗者優(yōu)先。
第5篇 整機(jī)集成及驗證主管工程師崗位職責(zé)描述崗位要求
職位描述：
職責(zé)描述：
1. 協(xié)助開展發(fā)動機(jī)研制需求分析、總要求的編制
2. 協(xié)助開展發(fā)動機(jī)研制型號規(guī)范的編制
3. 協(xié)助開展發(fā)動機(jī)驗證計劃的編制
4. 協(xié)助開展設(shè)計過程、與飛機(jī)集成等過程的飛/發(fā)技術(shù)協(xié)調(diào)
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(guān)工作
6. 協(xié)助開展試驗實施過程中的技術(shù)協(xié)調(diào)和試驗數(shù)據(jù)管理
7. 協(xié)助開展發(fā)動機(jī)設(shè)計需求管理
8. 協(xié)助開展本專業(yè)設(shè)計體系建設(shè)
職位要求：
1. 總體設(shè)計設(shè)計師任職3年以上，有總體設(shè)計、系統(tǒng)工程工作經(jīng)驗。
2. 航空宇航推進(jìn)專業(yè)、航空發(fā)動機(jī)專業(yè)等
3. 全日制大學(xué)本科及以上學(xué)歷
4. 具備航空發(fā)動機(jī)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(shù)報告或技術(shù)論文，有一定的英語口語交流能力，能較好地理解英文技術(shù)講座和報告
第6篇 qc驗證主管崗位職責(zé)
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.
