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Lilly QA Manager in Suzhou-苏州, China

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Primary Responsibilities :

  • 日常监督、检查和指导药品购进、验收、养护、保管、销售、运输等过程中的质量管理工作,对存在或反馈的质量问题或疑问应及时予以处理。Daily monitor/verify drug product quality of all process during receiving, storage, shipping, and responsible for handling quality issue/inquiry in time.

  • 负责原厂药检报告的翻译并将翻译件传递给仓库验收人员,对接受的产品进行验收复核,并及时在电子系统进行产品释放,符合GSP及礼来标准。To be responsible for the translation of COA and delivery it to warehouse personnel, and releasing incoming drug products on time to meet GSP and Lilly requirement.

  • 负责进行产品相关的偏差或事件的调查和处理,保证偏差的处理符合礼来GQS的相关要求, 并进行纠正、预防措施的有效实施与跟踪。To be responsible for conducting the investigation and handling of events related to the product, and ensuring the handling of the events meets the requirements of Lilly GQS. Effectively follow up the corrective and preventive actions

  • 负责质量退回产品、不合格药品的审核,对退回及不合格药品的处理过程实施监督。Returned / Rejected products check and judgement, and surveillance handling of returned / rejected products.

  • 收集药品质量标准,建立其相应的质量档案。Collect drug product specification, establish product profile.

  • 负责起草修订相关的SOPs,并作为文件系统Veeva QualityDocs的文件控制人, 维护良好的GSP文件系统。To be responsible for drafting and revising the SOPs, and as the main Veeva Quality Docs document controller (DC), maintain effective GSP documents system..

  • 仓库温度分布的定期测试方案的准备及执行. 保证仓库温湿度符合产品贮存条件。Preparation and execution of periodical warehouse mapping to ensure warehouse temperature and humidity meet product storage condition.

  • 协助保证LTC仓库的校验、设备设施的验证/确认工作,并制定每年的设施设备维护保养计划。Quality oversight on Calibration, Validations/Qualification for LTC warehouse facility/utility and develop Maintenance plan for systems each year.

  • 保证特殊产品及其他产品的安全性。Ensure special security substance and other products security.

  • 与仓库主管紧密合作,日常监督仓库的卫生,虫害控制,温温度控制等,及时发现情况并进行改正。Work together with warehouse supervisor closely, daily floor audit to warehouse, include pest control, hygiene, temperature/ humidity control, etc, and improve them appropriately in time.

  • 协调公司的个人培训和资质确认以及岗位职责文件的质量管理及员工健康档案。Take oversight on Personnel Training & Qualification as well as onJob descriptions and employee physical examination in LTC per GSP requirement.

  • 主管安排的工作Other tasks assigned by Supervisor.

Minimum Qualification Requirements

  • 本科或以上学历,药学,化学或相关专业。Bachelor degree or above, majored in pharmaceuticals, chemistry or related sciences

  • 至少一年的药品经营管理QA经验和GSP知识背景。At least one years of QA experience in drug product distribution/ wholesaler and GSP knowledge background.

  • 能用英语听,说和写Capable of listening, speaking and writing in English in fluency

  • 执业药师优先 License pharmacist preferred.

  • 积极勤奋,较强的执行和沟通能力Self-motivated and diligent, strong implementation and communication skill.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

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