长沙招聘

职位描述：
1. Principal Duties and Responsibilities (General Summary ，essential functions and authorities, etc.)
主要工作职责（基本概况，主要功能，权限等）
？ Quality management in distribution center of Shanghai
上海物流中心的质量管理：
？ Handle routine quality system management procedure in operation process in DC, such as NC, CAPA
处理物流中心日常的质量体系管理流程。如：不合格事件，纠正预防措施事件等。
？ Handle routine quality & operation procedure in DC. Such as GR release.
处理物流中心日常的质量操作流程,如产品放行。
？ Handle emergent quality issue.
处置紧急的质量事件。
？ Lead and manage QA 3rd PL Inspector in DC
负责和管理物流中心QA第三方现场检查员。
？ As Quality Eng, be team member of project in SH-DC, such as audit of internal, external and J&J ERC, etc.
作为质量工程师参加上海物流中心的项目。如：内部和外部质量审计，强生总部质量审计等。
？ Participant NC case and CAPA handling
不合格事件、纠正预防措施：
？ Handling the NC case until support DC QA head to close according to current GOP/SOP;
按照现行的GOP/SOP规定，在DC质量负责人的指导下及时处理并跟进不合格事件直至其结束。
？ Handling the CAPA support DC QA Head until close according to current GOP/SOP;
按照现行的GOP/SOP规定，在DC质量负责人的指导下及时处理并跟进产品和过程的纠正预防措施直至其结束。
？ Inspection for the import product
进口产品的货物检查：
？ Responsible for the routine check and review for the imported product, complete the checking report in time, and manage the report document.
负责日常进口产品货物检查和核对，按时完成货物检查报告，并管理检查报告文档。
？ Responsible for the check and evaluate the complaint of the imported product during inspection, ensure the complaint is correct and suitable, manage and upload the complaint document data
负责对在日常进口产品货物检查过程中所产生的投诉事件进行核对和评估，确保其准确和合适，管理投诉事件数据归档和上传。
？ Inspection for the return product
退货产品的货物检查：
？ Implement the return product checking, complete and manage the checking report
对退货产品执行货物检查，完成日常的退货产品检查报告，并管理检查报告文档。
？ Be dispose the communication problem produced by return product and provide the solution project for franchise and distributors if necessary.
在必要的时候处理因产品退货而产生的沟通问题，为产品事业部、经销商提供解决方案。
？ Goods release and handle
产品的放行与处置
？ Responsible for the release or hold or handle goods in according to the JJMS’s quality of requirements.
负责按JJMS的质量要求对产品进行放行，暂存或其他处置。
？ Routine monitor in warehouse (if necessary)
仓库的日常监控(如必要)：
？ Monitor the temperature / humidity record in the third part’s warehouse in SH-DC and ensure that comply with the product storage requirement.
日常管理SH-DC仓库的温湿度记录作核对和评估，确保其符合产品储存的要求。
？ Monitor the temperature / humidity calibration label in SH-DC, awake the QA Site Leader and third part person recalibrate before two months and follow up it be finished.
管理SH-DC仓库的温湿度记录仪校验标识：到期前两个月提醒物流中心QA负责人以及第三方管理物流人员，并一直跟踪直至再次校验结束。
？ Monitor and check the insect pest control record, promptly inform the QA Site Leader if discover not normal case.
管理审核仓库的虫害控制记录，如有非正常情况，立即报告物流中心QA负责人。
？ Monitor the import product storage and shipment environment to provide the complied evidence. Promptly inform the QA Site Leader if discover not normal case.
监控进口产品的储存和运输环境，提供产品符合性依据；如有非正常情况，立即报告物流中心QA负责人。
？ Quality management for imported product Chinese label, Chinese IFU
进口产品中文标签/中文说明书的质量管理：
？ Chinese label inspection: supervise the process of first article, GR releasing, filing, photos and documentation & statistic
中文标签检查：首件检查、放行和过程中监控，文件、照片和报告留档和统计.
？ Complete the check for Chinese label/Chinese IFU of the initial create and the change in SAP system and release the related product. Contact with related Dept. for content correction if the CN label is not correct. Ensure only correct labels are released.
在SAP系统中，及时完成初次产生和变更的中文标签/中文说明书的核对工作，并放行相关的产品的中文标签；对于不合格的标签，与相关部门沟通，确保正确标签的放行．
？ Inspects Chinese label/Chinese IFU that was doubted inaccurate. If necessary, prepare rework protocol to correct the Chinese label for the storage product；
对怀疑错误的中文标签/中文说明书进行检查，必要时，准备返工草案并递交审批，并对库存产品实施产品中文标签的现场纠正；
？ Good inspection: inspect doubted or inaccurate receiving goods then documentation report, filing and statistic
中文说明书检查：来料中文说明书检查和过程中监控，文件、报告留档和统计
？ Issued JJMS product quality certification
签发JJMS产品质量证明
？ Handle emergent quality issue in according to quality requirements.
按要求处置紧急的质量事件。
？ Other responsibilities defined in written procedures.
流程中规定的其它职责。

2. Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
基本任职资格（包括教育背景和/或知识和/或培训和/或相关工作经验）
？ Bachelor degree on chemical, pharmaceutical, medical device related subjects.
大学毕业，化学、制药或医疗器械及相关专业
？ Above 3～5 years’ experience in quality compliance management or related areas in medical device or pharmaceutical industries.
3～5年以上医疗器材或医药相关质量工作经验
？ Good communication, cooperation and organization skills.
优良的沟通、协调和组织能力
？ English good enough in reading, writing, oral, listening.
熟练的英语读、写和听能力
？ Familiar with routine operations of computer and software.
熟练的基本计算机和软件操作能力 举报 分享

强生（上海）医疗器材有限公司诚聘