职位描述
职位描述：
岗位描述：
Position Brand Description:
执行湖东工厂包装操作日常在线质量监控，过程检查和其他相关的质量活动(例如：批记录审核，质量问题处理)，确保整个包装过程和产品的质量得到控制并符合所有适用的法规要求和礼来公司的质量要求。
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.
主要职能：
Key Objectives/Deliverables:
以下职能主要支持礼来苏州湖东工厂,在有资质的情况下可支持苏州其他工厂
The following objectives mainly related to Lilly Suzhou Pharmaceutical East Lake Branch，and can support other site in Lilly Suzhou if related qualified appropriate.
-对所有涉及分包装产品的包装过程进行在线的质量监控，确保包装过程中的所有工序符合政府法规和礼来质量标准的要求。
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.
-进行现场检查和包装过程控制,确保这些检查项目符合可接受标准。
Conduct shop floor inspection and packaging in process control and make sure all inspected item can meet acceptance criteria.
-在批生产记录上记录中间体分析结果，审核通过后批准进入下一道工序。
Document in-process control results on batch records and review it for further process step.
-负责生产现场每批生产前后清场的确认。
Responsible for confirmation of line clearance before and after production.
-负责生产现场质量相关问题的处理与判定，确保生产活动符合法规、礼来质量要求并与确认和/或验证状态保持一致。
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.
-负责对包装成品的取样,送样以及样品的保存
Responsible for sampling of ID samples and finished product, and sample storage management.
-审核所有的批记录和包装区域其它相关的质量记录
To review all the batch records and related quality documents at packaging area
-对完成的批记录和其他相关记录进行检查，确保记录完整准确。
Review completed batch record and other related record to ensure data completeness and accuracy.
-负责审核和追踪有可能影响产品安全性、一致性、效价、品质或纯度的偏差和中间体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.
-负责审阅包装区域与质量相关的记录(例如：人员资质认定，产线使用记录等)的定期审阅。
Responsible for periodic review of quality documents (e.g. operation Qualification Program, logbooks for packaging line) at packaging area.
-GQS实施与质量体系改进。
GQS implementation and improvement in quality systems.
-及时了解与学习GQS的更新文件。
Learn the newest version of GQS documentation timely.
-及时将GQS的质量体系运用到本地质量程序的改进。
Apply the newest GQS to Suzhou local quality procedures.
-审核相应部门的SOP和WI， 确保相应的流程和操作符合GQS和GMP的要求
Review related department’s SOP and WI to insure its compliance to GQS and GMP requirements.
-参与和实施HSE和5S相关的特定的任务
Participate in and implement specific tasks regarding HSE and 5S activities
-其他与质量管理相关的事项。
Other tasks related to QA.
-执行年度留样检查计划
Execute annual house sample inspection plan
-参与偏差调查、变更实施和投诉调查
Participate in deviations, change controls and complaint investigation
-对职责相关的记录文件修订审阅，并及时进行归档
Prepare, review and archive records and documentation related to duty.
-对发放的批记录进行检查，确保其清晰,完整以及版本正确。
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:
-大专及以上学历，药学化学或相关学科
Associate degree or above, majored in pharmaceuticals, chemistry or related sciences
-1-3年的生产或QA经验
One to three years of experience in production or QA
-能用英语阅读
Capable of reading in English
-执业药师优先考虑
License pharmacist, preferred.
