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Job Information

Lilly QA Specialist in 上海,

Job Category:

医学

Type of Employment:

合同工

Responsibilities:

负责根据礼来全球质量标准及本地程序进行中国区域投诉处理;对内外部患者/客户支持项目,患者援助项目和/或其他创新项目(即各投诉报告来源)进行质量监督,以确保投诉的上报。

Be responsible for the complaints handling activities in China per GQS130 and local standard operation procedures; and providing quality oversight to internal/external parties (i.e. reporting source) regarding specific Patient/Customer Support Program, Patient Assistant Program and/or other innovative projects to ensure PC reporting.

  1. 作为产品投诉处理专员,负责中国区域产品的投诉处理,包括但不限于以下职责:

To be the Responsible Complaint Person (RCP) of China Affiliate to manage the product complaints in China, including but not limited to the routine activities mentioned below:

a) 收集必要的投诉信息,在投诉系统中建立、追踪投诉记录并确保投诉案件按照礼来全球要求在45个自然日内关闭;

Collect the complaint data as required, create and track the complaint records in Trackwise System and ensure the incident can be closed within 45 calendar days to meet Lilly global requirements;

b) 投诉样品管理,样品接收并寄出至亚太投诉中心或负责投诉调查的生产/包装工厂。

Complaint sample management, to follow up complaint sample retrieval and arrange sample shipment to Asia Pacific Regional Center (APRC) or manufacturing/packaging site for complaint investigation.

c) 客户投诉回复。(如需要)

Complaint response to customers if needed.

d) 协助报告礼来产品疑似假药事件。

Support suspect reporting of Lilly products.

e) 起草并更新礼来上市产品标准技术信息问答文件。

Develop and update the Technical Response Document (TRD) for Lilly products in the market.

f) 投诉数据分析,监控产品投诉趋势及可能引起的产品质量或患者安全问题。

Complaint data mining, to monitor the product complaint trends/incidents that may indicate a potential quality or patient safety issue.

g) 密切配合亚太投诉中心/跨部门团队处理投诉事宜。

Work closely with APRC/cross-functional teams to handle complaint activities or issues.

  1. 负责产品投诉相关的培训材料更新,基于需求与患者安全部门共同开展有关礼来不良事件以及产品投诉的内外部培训。

Manage PC related training material update and coordinate with Patient Safety team to conduct Lilly AE/PC training to internal/external parties upon request.

  1. 定期进行产品投诉趋势分析回顾和指标更新。

Conduct periodic review of product complaint trend analysis report and metrics update.

  1. 为确保产品投诉及时上报,避免上报遗漏,与礼来各相关团队、外部呼叫中心或其他项目进行案子接收确认和AE/PC的定期衡算。

Be responsible for the confirmation of receipt as well as reconciliation of AE/PC events with Lilly cross-functional team, external call center and other innovative programs (PSP/CSP/PAP/PEP/PBP/CSO) to ensure the timely case reporting and no miss of PC.

  1. 根据礼来全球政策与指导,负责完善产品投诉相关的流程或质量协议的更新。

To be responsible for local complaint procedure/quality agreement updates in accordance with global policy/guidance.

  1. 主管安排的其他工作

Perform other related duties as assigned by Supervisor.

Basic Qualificiations:

Minimum Qualification Requirements: [List requirements for education, experience, skills and any required certifications. See examples below.]

• 本科及以上学历,药学,化学或相关专业

Bachelor degree or above in a pharmaceuticals, chemistry or related sciences

• 至少3年的医药行业GMP/GSP质量管理经验,或投诉处理经验

At least three years working experience in quality GMP/GSP role in Pharmaceutical Industry, and/or complaint handling practices

• 能用英语进行流利地听说读写

Capable of listening, speaking and writing in English in fluency

Other Information/Additional Preferences:

 Excellent communication (written and verbal), organizational and negotiation skills required, self-motivated and proactive.

良好的沟通能力(书面及口语),组织能力,磋商能力及其积极主动的能力。

 Strong knowledge of quality systems

扎实的质量知识。

Additional Skills/Preferences:

Additional Information:

Company Overview:

Posted Date:

Keyword:

Region: 亚洲/太平洋地区

City: 上海

State: 上海市

Country: 中国

Location Details:

Req Id: 50325BR

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