上海招聘

• Execution of quality oversight of product life cycle and its manufacturing process

在产品生命周期中及端到端的制造过程实施质量监管

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2. Execute frontline QA activities in manufacturing area at JW WGQ site
3. 在JW 外高桥工厂生产现场的QA活动
4. Acknowledge the live status in production area according to the DPS and follow up with actual excursions against the DPS, identify the potential risks and take preventive action.
5. 生产计划，实时了解生产动态, 对实际生产情况与生产计划的偏离进行现场跟进，辨识潜在的质量风险，进行提前预防.
6. Join Tier meeting in production or other Tier meetings
7. 生产部例会或其他层级会议
8. Enabling real-time problem solving with production team
9. 与生产团队共同实时解决问题
10. Provide comprehensive quality support and perform QA oversight of JW WGQ site  Environmental Monitoring (EM) and Clean Utility Monitoring programs
11. JW 外高桥工厂环境监控和洁净公用设施提供全面的质量支持和实施QA质量监管
12. Perform QA oversight of the Engineering department including calibration and preventative maintenance program and work order process
13. 程部门进行质量检查监督，包括校准和预防性维护计划和工作流程
14. Perform QA oversight of Warehouse Operation where applicable
15. 用的情况下实施仓库运营的QA监督
16. Perform QA oversight of QC lab
17. /span>QC实验室实施QA监督
18. Oversight material release activities executed by QC
19. /span>QC执行物料放行进行监督
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21. Execution of Batch Record Review process for product
22. 产品的批记录审核
23. Ensure each production batch is produced and controlled in accordance with the requirements of regulations and the company SOPs

确保每批产品的生产受控、符合法规及公司相关SOP和要求

• 对生产性物料实施QA质量监管
• ecution of QA oversight on productive materials
• 对生产性物料及时放行
• rform productive material released on-time
• 对关键物料/产品的库存进行监督（如Vector，CMAT/CDP）
• ersight the inventory of key material/products(Vector, CMAT/CDP)
• 对物料质量的以下方面实施监管，包含系统主数据、变更、偏差/CAPA等方面
• ersee material quality including system master data, Change, DMS/CAPA etc.
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• Execution of Deviation handling, CAPA and Change Control Management to ensure quality and compliance of these activities meet local HA requirements
• /span>QA偏差处理、CAPA以及变更控制管理的执行实施监管以确保其质量和符合性达到本地药监部门的要求。
• Ensure investigation related to manufacturing is appropriately conducted considering robust analysis, documentation of root causes and identifying potential risks to operations and product quality
• 产品制造过程的调查充分、根本原因分析合理可靠、对产品潜在质量风险已被识别并记录
• Ensure appropriate remediation is identified that will address root cause and proactively prevent similar events from occurring
• 针对根本原因的及为预防类似事件发生的合适的补救行动已被定义
• Implementation of Change control is appropriately conducted considering reasonable classification, organizing CCRB, clear documentation of change plan & actions and verification of change effectiveness if necessary
• 控制的执行，包括合理分级，组织变更审核会，明确变更计划和行动以及必要时对变更有效性的确认
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• Inform Quality Management about significant issues that require escalation according to the internal requirements
• 内部要求，将重大隐患上报质量管理团队
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• Perform quality oversight for complaint and recall according to internal requirements
• 内部要求，进行投诉和召回的质量监管
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• Documentation文件工作
• rform documents (such as SOP) preparation.
• 有关文件（如SOP）的起草工作
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• Supporting on Commercial Product Marketing Release

支持商业化产品上市放行

• Complete the other tasks assigned by senior leaders

完成上级领导交办的其它任务

key Interfaces:

l  PD, MFG,QC, ENG, Supply Chain, Warehouse, Safety, IT

研发、生产、QC、工程、供应链、仓贮、安全, IT

l  Other Quality Functions

其它质量职能部门

教育、资质和经验/Education, Qualifications and Experience

●        Education/Qualifications教育程度/所获资格证书

• Bachelor Degree (4 years education of Pharmacy, Pharmaceutical, bioengineering, Chemistry or equivalent education level) , Graduate or higher-level Degree is preferred
• 学位（4年药学、制药、生物工程、化学或同等学历）, 更高学历优先

●        Experience (may vary depending on site size/scope)

经验（基于工厂规模和范围可适当调整）

• 5 or more years’ work experience in the pharmaceutical or related industry
• /span>年以上制药或相关工厂工作经验

●      Knowledge/Skills/Competencies

知识、技能、能力

• Good accountability of GMP understanding and implementing.
• 的GMP理解贯彻能力。
• Knowledge and experience in production and quality management.
• 生产、质量管理的知识和经验。
• Well communication skill and good accountability of problem solving.

良好的沟通,解决问题的能力。

PC skill/ PC技能:  MS Office, 

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定位与愿景：
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