崗位描述:保證實驗室操作規(guī)程符合 GMP 和公司政策并貫徹執(zhí)行。確保灌裝實驗室設(shè)備的質(zhì)量體系,準(zhǔn)備設(shè)備的 UR、描述以及確認(rèn)文件,執(zhí)行設(shè)備安裝確認(rèn),所有設(shè)備確認(rèn)行為須按時完成。(該崗位服務(wù)周期是6-10個月)
主要職能:
建立分析儀器驗證方案并完成報告。
Design analytical equipment qualification protocol and complete report.
? 負(fù)責(zé)實驗室設(shè)備的管理,確保設(shè)備的驗證和使用符合中國 GMP 和公司 GQS605 的要求。
To take responsibility for laboratory analytical equipment installation, and make sure the equipment qualification activities should be complied with both Chinese GMP and GQS605 requirement.
? 起草部分設(shè)備驗證方案、預(yù)防性維護方案、校驗方案。起草部分設(shè)備操作規(guī)程。
To prepare some equipment qualification protocol, preventive maintenance, calibration protocol and working instruction.
? *根據(jù) GMP 要求有序,有組織地書寫驗證報告和其它文件。
To prepare the verification reports and other documents in order and organized format according to the GMP requirement.
? 負(fù)責(zé)分析儀器的初始驗證,再驗證。
Responsible for analytical equipment initial qualification/re-qualification.
? 在期望的時間內(nèi)根據(jù)批準(zhǔn)的驗證方案(英文)來進行實驗室設(shè)備驗證工作。
To perform lab equipment qualification according to the approved qualification protocol (English) within the desired lead time
制定年度內(nèi)部和外部校正計劃,儀器設(shè)備的更新計劃及其他設(shè)備管理相關(guān)事務(wù)。
Respond to maintain annual internal and external instrument calibration plan, equipment & instrument replace plan, and other activities for equipment & instrument in lab.
? 根據(jù)規(guī)程的要求,預(yù)先對設(shè)備和儀器進行校正保養(yǎng)和維修保養(yǎng)。協(xié)調(diào)設(shè)備的計量校驗。
To perform the equipment calibrations and maintenance according to the procedures on a preplanned schedule. Coordinate the equipment calibration.
? 協(xié)助 GLIMS 系統(tǒng)實施。
To assist with GLIMS deployment.
? 做其他與質(zhì)量相關(guān)的事項。
To assume other tasks related to Quality.
? 協(xié)助實驗室質(zhì)量體系的持續(xù)改進提高。
To assist with lab quality system continuously improvement.
? *遵守 HSE 各項管理流程,履行安全生產(chǎn)職責(zé)要求。
Follow various HSE management procedures and fulfil the work safety responsibilities