職位描述
職位描述：
崗位描述：
Position Brand Description:
執(zhí)行湖東工廠包裝操作日常在線質(zhì)量監(jiān)控，過(guò)程檢查和其他相關(guān)的質(zhì)量活動(dòng)(例如：批記錄審核，質(zhì)量問(wèn)題處理)，確保整個(gè)包裝過(guò)程和產(chǎn)品的質(zhì)量得到控制并符合所有適用的法規(guī)要求和禮來(lái)公司的質(zhì)量要求。
Execute daily on site quality oversight, in process control and other related quality activities（e.g. batch record review and quality issue handling） to make sure whole packaging process and drug product quality are in good control and meet all applicable regulatory requirements and Lilly quality requirements.
主要職能：
Key Objectives/Deliverables:
以下職能主要支持禮來(lái)蘇州湖東工廠,在有資質(zhì)的情況下可支持蘇州其他工廠
The following objectives mainly related to Lilly Suzhou Pharmaceutical East Lake Branch，and can support other site in Lilly Suzhou if related qualified appropriate.
-對(duì)所有涉及分包裝產(chǎn)品的包裝過(guò)程進(jìn)行在線的質(zhì)量監(jiān)控，確保包裝過(guò)程中的所有工序符合政府法規(guī)和禮來(lái)質(zhì)量標(biāo)準(zhǔn)的要求。
Perform on site quality oversight for repackaging process of all repacked drug product and make sure all of them can meet government regulation and Lilly quality requirements.
-進(jìn)行現(xiàn)場(chǎng)檢查和包裝過(guò)程控制,確保這些檢查項(xiàng)目符合可接受標(biāo)準(zhǔn)。
Conduct shop floor inspection and packaging in process control and make sure all inspected item can meet acceptance criteria.
-在批生產(chǎn)記錄上記錄中間體分析結(jié)果，審核通過(guò)后批準(zhǔn)進(jìn)入下一道工序。
Document in-process control results on batch records and review it for further process step.
-負(fù)責(zé)生產(chǎn)現(xiàn)場(chǎng)每批生產(chǎn)前后清場(chǎng)的確認(rèn)。
Responsible for confirmation of line clearance before and after production.
-負(fù)責(zé)生產(chǎn)現(xiàn)場(chǎng)質(zhì)量相關(guān)問(wèn)題的處理與判定，確保生產(chǎn)活動(dòng)符合法規(guī)、禮來(lái)質(zhì)量要求并與確認(rèn)和/或驗(yàn)證狀態(tài)保持一致。
Responsible for dealing with quality issues at production area to make sure production operation can comply with regulatory and Lilly quality requirements and it is consistent with qualified and/or validated status.
-負(fù)責(zé)對(duì)包裝成品的取樣,送樣以及樣品的保存
Responsible for sampling of ID samples and finished product, and sample storage management.
-審核所有的批記錄和包裝區(qū)域其它相關(guān)的質(zhì)量記錄
To review all the batch records and related quality documents at packaging area
-對(duì)完成的批記錄和其他相關(guān)記錄進(jìn)行檢查，確保記錄完整準(zhǔn)確。
Review completed batch record and other related record to ensure data completeness and accuracy.
-負(fù)責(zé)審核和追蹤有可能影響產(chǎn)品安全性、一致性、效價(jià)、品質(zhì)或純度的偏差和中間體或成品的再加工或返工。
Responsible for review and approval of the deviations that is potential to impact product’s SISPQ, and reprocessing or reworking of an intermediates/drug product.
-負(fù)責(zé)審閱包裝區(qū)域與質(zhì)量相關(guān)的記錄(例如：人員資質(zhì)認(rèn)定，產(chǎn)線使用記錄等)的定期審閱。
Responsible for periodic review of quality documents (e.g. operation Qualification Program, logbooks for packaging line) at packaging area.
-GQS實(shí)施與質(zhì)量體系改進(jìn)。
GQS implementation and improvement in quality systems.
-及時(shí)了解與學(xué)習(xí)GQS的更新文件。
Learn the newest version of GQS documentation timely.
-及時(shí)將GQS的質(zhì)量體系運(yùn)用到本地質(zhì)量程序的改進(jìn)。
Apply the newest GQS to Suzhou local quality procedures.
-審核相應(yīng)部門(mén)的SOP和WI， 確保相應(yīng)的流程和操作符合GQS和GMP的要求
Review related department’s SOP and WI to insure its compliance to GQS and GMP requirements.
-參與和實(shí)施HSE和5S相關(guān)的特定的任務(wù)
Participate in and implement specific tasks regarding HSE and 5S activities
-其他與質(zhì)量管理相關(guān)的事項(xiàng)。
Other tasks related to QA.
-執(zhí)行年度留樣檢查計(jì)劃
Execute annual house sample inspection plan
-參與偏差調(diào)查、變更實(shí)施和投訴調(diào)查
Participate in deviations, change controls and complaint investigation
-對(duì)職責(zé)相關(guān)的記錄文件修訂審閱，并及時(shí)進(jìn)行歸檔
Prepare, review and archive records and documentation related to duty.
-對(duì)發(fā)放的批記錄進(jìn)行檢查，確保其清晰,完整以及版本正確。
Verify issued batch record and packaging order to ensure it is printed clearly and completely as well as the correct version.
基本要求：
Basic Requirements:
-大專及以上學(xué)歷，藥學(xué)化學(xué)或相關(guān)學(xué)科
Associate degree or above, majored in pharmaceuticals, chemistry or related sciences
-1-3年的生產(chǎn)或QA經(jīng)驗(yàn)
One to three years of experience in production or QA
-能用英語(yǔ)閱讀
Capable of reading in English
-執(zhí)業(yè)藥師優(yōu)先考慮
License pharmacist, preferred.
