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工作內(nèi)容：
1.負責監(jiān)督制劑生產(chǎn)車間的現(xiàn)場操作按照GMP、SOP及批生產(chǎn)記錄進行操作，確保生產(chǎn)操作的一致性及合規(guī)性；
Responsible for supervising the on-site management of the DP Plant, to ensure the consistency and compliance of production operation in accordance with GMP, SOP and BPR requirement;
2.負責監(jiān)督制劑生產(chǎn)車間的SOP、記錄執(zhí)行情況，確保SOP及記錄為現(xiàn)行版本，并確保記錄的填寫符合數(shù)據(jù)完整性相關(guān)要求；
Responsible for the management of document and record in DP Plant, to make sure SOP and record was the current version, and to make sure that record in accordance with the requirements of data integrity;
3.負責監(jiān)督制劑生產(chǎn)車間的狀態(tài)標識執(zhí)行情況，確保車間各項狀態(tài)標識管理符合SOP要求；
Responsible for the management of identification label in DP Plant, to make sure the implementation of status identification in accordance with the SOP requirement;
4.負責監(jiān)督制劑生產(chǎn)車間的清潔、清場執(zhí)行情況，確保清潔、清場操作符合SOP要求；
Responsible for the management of Clearance/Cleaning in DP Plant, to make sure the implementation of Clearance/Cleaning operation in accordance with the SOP requirement;
5.負責制劑生產(chǎn)車間空氣凈化系統(tǒng)、純化水系統(tǒng)、壓縮空氣系統(tǒng)等公用設施的現(xiàn)場管理，確保公用設施的運行、維護保養(yǎng)、記錄等符合要求；
Responsible for the management of facility（including HVAC system、PW system、Compress air system） in DP Plant, to make sure the operation & maintenance of facility in accordance with the SOP requirement;
6.負責根據(jù)文件要求起草及審核公用系統(tǒng)趨勢分析；
Responsible for the quality review report of facility（including HVAC system、Compress air system）;
7.負責審核制劑生產(chǎn)車間計量器具分類清單、校準計劃及校準記錄,確保制劑生產(chǎn)車間的計量器具管理符合SOP要求，并根據(jù)校準報告發(fā)放校準標簽；
Responsible for the management of measuring instrument in DP Plant, to make sure the implementation of measuring instrument（including Classification List 、Calibration Plan、Calibration Record） in accordance with the SOP requirement; Deliver the Calibration Label to DP Plant after the review of Calibration Certificate report;
8.完成本部門領(lǐng)導臨時安排的工作。
Complete other tasks arrangements by department head.
教育背景 Education Background
1.化學、應用化學、藥學或相關(guān)專業(yè)本科以上學歷
Bachelor degree or college degree above in chemistry, applied chemistry, pharmacy or other related on-sites.
2.應當至少具有藥學或相關(guān)專業(yè)本科或?qū)？茖W歷（或中級專業(yè)技術(shù)職稱或執(zhí)業(yè)藥師資格）。本科學歷，具有至少1年從事藥品生產(chǎn)和質(zhì)量管理的實踐經(jīng)驗，接受過與所生產(chǎn)產(chǎn)品相關(guān)的專業(yè)知識培訓。大專學歷（或中級專業(yè)技術(shù)職稱或執(zhí)業(yè)藥師資格），具有至少2年從事藥品生產(chǎn)和質(zhì)量管理的實踐經(jīng)驗，接受過與所生產(chǎn)產(chǎn)品相關(guān)的專業(yè)知識培訓。
A bachelor degree or college degree above in pharmacy other related on-site (or qualified mid-level with the title in professional or licensed pharmacist), bachelor
degree, more than 1 years of experience in drug production and quality management, trained in professional knowledge related to the products produce.
college degree (or qualified mid-level with the title in professional or licensed pharmacist), more than 2 years of experience in drug production and quality management, trained in professional knowledge related to the products produce.