職位描述
職位描述：
崗位描述：
Position Brand Description:
執行湖東工廠包裝操作日常在線質量監控，過程檢查和其他相關的質量活動(例如：批記錄審核，質量問題處理)，確保整個包裝過程和產品的質量得到控制并符合所有適用的法規要求和禮來公司的質量要求。
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蘇州湖東工廠,在有資質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.
-對所有涉及分包裝產品的包裝過程進行在線的質量監控，確保包裝過程中的所有工序符合政府法規和禮來質量標準的要求。
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.
-進行現場檢查和包裝過程控制,確保這些檢查項目符合可接受標準。
Conduct shop floor inspection and packaging in process control and make sure all inspected item can meet acceptance criteria.
-在批生產記錄上記錄中間體分析結果，審核通過后批準進入下一道工序。
Document in-process control results on batch records and review it for further process step.
-負責生產現場每批生產前后清場的確認。
Responsible for confirmation of line clearance before and after production.
-負責生產現場質量相關問題的處理與判定，確保生產活動符合法規、禮來質量要求并與確認和/或驗證狀態保持一致。
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.
-負責對包裝成品的取樣,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域其它相關的質量記錄
To review all the batch records and related quality documents at packaging area
-對完成的批記錄和其他相關記錄進行檢查，確保記錄完整準確。
Review completed batch record and other related record to ensure data completeness and accuracy.
-負責審核和追蹤有可能影響產品安全性、一致性、效價、品質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.
-負責審閱包裝區域與質量相關的記錄(例如：人員資質認定，產線使用記錄等)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實施與質量體系改進。
GQS implementation and improvement in quality systems.
-及時了解與學習GQS的更新文件。
Learn the newest version of GQS documentation timely.
-及時將GQS的質量體系運用到本地質量程序的改進。
Apply the newest GQS to Suzhou local quality procedures.
-審核相應部門的SOP和WI， 確保相應的流程和操作符合GQS和GMP的要求
Review related department’s SOP and WI to insure its compliance to GQS and GMP requirements.
-參與和實施HSE和5S相關的特定的任務
Participate in and implement specific tasks regarding HSE and 5S activities
-其他與質量管理相關的事項。
Other tasks related to QA.
-執行年度留樣檢查計劃
Execute annual house sample inspection plan
-參與偏差調查、變更實施和投訴調查
Participate in deviations, change controls and complaint investigation
-對職責相關的記錄文件修訂審閱，并及時進行歸檔
Prepare, review and archive records and documentation related to duty.
-對發放的批記錄進行檢查，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:
-大專及以上學歷，藥學化學或相關學科
Associate degree or above, majored in pharmaceuticals, chemistry or related sciences
-1-3年的生產或QA經驗
One to three years of experience in production or QA
-能用英語閱讀
Capable of reading in English
-執業藥師優先考慮
License pharmacist, preferred.
