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QA Manager - Materials

Suzhou, China

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Req ID R-26738 Title QA Manager - Materials City Suzhou State / Province Shanghai Country 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.

Organization Overview:

此岗位的职能是苏州湖东工厂高级物料QA经理。在此岗位上,员工将负责管理礼来苏州湖东工厂使用的物料和相关供应商,以及发运工作。本岗位将确保礼来的物料仓储管理、供应商管理和产品发货工作是根据礼来公司质量体系进行风险评估,并符合法规及礼来公司质量体系要求。

The purpose of this role is to serve as the Materials QA leader for the Suzhou East Lake plant. In this role, the employee will be responsible to manage the qualification of materials & warehouse management, associated vendor management for use and distribution in Lilly Suzhou East Lake site. The role will ensure Lilly materials warehouse and vendor management works are risk assessed according to the Lilly Quality System, and incompliance with requirement of Regulatory and Lilly Quality System.



Responsibilities:

以下职能范围包含礼来苏州工厂。

Scope of below responsibility includes Lilly Suzhou site.

  • 负责物料的取样、PPC/PPM检测及释放
  • Be responsible for materials sampling, PPC/PPM testing and releasing.
  • 质量标准的制定和管理
  • Specification creation and management
  • 确保运输要求符合相应的GQSGXP的要求
  • Ensure the distribution practice meet the requirement for GQS and GXP.
  • GQS实施与质量体系改进
  • GQS implementation and improvement in quality systems.
  • 员工发展
  • Personnel Development
  • 领导和监管供应商管理流程体系
  • Lead and oversight of site vendor management processes (supplier/service provider)
  • 参与物料运营团队活动,建立跨部门质量合作文化
  • Participate in Material PT and build up cross-functional Quality culture

做其它和质量有关的事项

To assume other tasks related to Quality

  • 根据GQS和当地政府的法规要求修改和完善礼来苏州的SOP
  • To revise or develop Lilly Suzhou SOPs according to GQS and local government regulations.
  • 参与公司内部审计。
  • To take part in the internal Site Self assessment /GMP audit for compliance.
  • 负责起草修改职责相关的SOPs
  • To be responsible for drafting and revising the SOPs related to duty.
  • 参与偏差调查、变更执行。
  • To take part in deviation, change.
  • 确保各部门的操作行为符合政府法规和礼来质量标准的要求。
  • To ensure that each department’s operation meets the requirements of local government regulations and Lilly standards.
  • 积极参与建设质量文化。
  • Engage in building up quality culture.
  • 其他任务由主管安排。
  • Other task assigned by supervisor.

Basic Requirements:

  • 本科及以上
  • Bachelor degree or above
  • GMP环境工作经验
  • Previous experience working in a GMP environment
  • 流利的英文听说读写能力
  • Capable of speaking, writing and reading English fluently


Additional Skills/Preferences:

  • 对GMP有很好的理解,并且之前有药厂或QA工作经验
  • Understanding of Good Manufacturing Practices, with previous experience in Pharmaceutical production or QA

  • 组织能力强,能够建立计划并推进其按照计划完成
  • Strong organization skills and the demonstrated ability to develop a plan and drive the timely execution.

  • 人际关系处理技巧,主动沟通并能够和不同国家人员交际
  • Inter-personal skills including working multi-nationally and communicating proactively.


Additional Information:

  • 少量的出差,包括美国或欧洲的商务差旅需求
  • Minimal travel but ability for some business trips to the US or Europe
  • 8小时工作制,一周工作五天,但有可能由于海外电话会议导致加班
  • 8 hour work days, Monday through Friday, but the ability to participate on off-hour teleconferences with the US and / or Europe.
  • 2-3年团队管理经验
  • 2-3 years previous management experience

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 ( Lilly_Recruiting_Compliance@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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-26738.

Lilly is an EEO/Affirmative Action Employer and 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.

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