工作內(nèi)容：
1.負(fù)責(zé)監(jiān)督制劑生產(chǎn)車(chē)間的現(xiàn)場(chǎng)操作按照GMP、SOP及批生產(chǎn)記錄進(jìn)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(fù)責(zé)監(jiān)督制劑生產(chǎn)車(chē)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(xiě)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(fù)責(zé)監(jiān)督制劑生產(chǎn)車(chē)間的狀態(tài)標(biāo)識(shí)執(zhí)行情況，確保車(chē)間各項(xiàng)狀態(tài)標(biāo)識(shí)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(fù)責(zé)監(jiān)督制劑生產(chǎn)車(chē)間的清潔、清場(chǎng)執(zhí)行情況，確保清潔、清場(chǎng)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(fù)責(zé)制劑生產(chǎn)車(chē)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(shè)施的現(xiàn)場(chǎng)管理，確保公用設(shè)施的運(yùn)行、維護(hù)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(fù)責(zé)根據(jù)文件要求起草及審核公用系統(tǒng)趨勢(shì)分析；
Responsible for the quality review report of facility（including HVAC system、Compress air system）;
7.負(fù)責(zé)審核制劑生產(chǎn)車(chē)間計(jì)量器具分類清單、校準(zhǔn)計(jì)劃及校準(zhǔn)記錄,確保制劑生產(chǎn)車(chē)間的計(jì)量器具管理符合SOP要求，并根據(jù)校準(zhǔn)報(bào)告發(fā)放校準(zhǔn)標(biāo)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(mén)領(lǐng)導(dǎo)臨時(shí)安排的工作。
Complete other tasks arrangements by department head.
教育背景 Education Background
1.化學(xué)、應(yīng)用化學(xué)、藥學(xué)或相關(guān)專業(yè)本科以上學(xué)歷
Bachelor degree or college degree above in chemistry, applied chemistry, pharmacy or other related on-sites.
2.應(yīng)當(dāng)至少具有藥學(xué)或相關(guān)專業(yè)本科或?qū)？茖W(xué)歷（或中級(jí)專業(yè)技術(shù)職稱或執(zhí)業(yè)藥師資格）。本科學(xué)歷，具有至少1年從事藥品生產(chǎn)和質(zhì)量管理的實(shí)踐經(jīng)驗(yàn)，接受過(guò)與所生產(chǎn)產(chǎn)品相關(guān)的專業(yè)知識(shí)培訓(xùn)。大專學(xué)歷（或中級(jí)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(shí)踐經(jīng)驗(yàn)，接受過(guò)與所生產(chǎn)產(chǎn)品相關(guān)的專業(yè)知識(shí)培訓(xùn)。
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.