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Lilly Associate-QA Area in Suzhou Manufacturing-苏州工厂, 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.

岗位描述:

Position Brand Description:

负责礼来苏州外部仓库区域的质量监控和已释放产品的质量管理。

Perform quality oversight of off-site warehouse and quality management of post-release product.

主要职能:

Key Objectives/Deliverables:

以下职能主要支持礼来苏州工厂。

The following objectives are mainly related to Lilly Suzhou .

  • 监督外部仓库的日常运行,包括产品接收、储存、保养、运输等,确保操作和管理符合相关法规的要求,并对已释放产品进行质量管理。

Oversee off-site warehouse operation, including product receipt, storage, maintenance and shipping etc., ensure the operation and management comply with related regulatory requirement, and give the quality management for post-release product.

  • 监督管理外部仓库的验证状态。

Oversee the validation status of off-site warehouse.

  • 更新储存在外部仓库产品的质量状态。

Change the quality status of finished product stored in off-warehouse.

  • 批准退货产品的批处置。

Approve the batch decision on returned product.

  • 定期检查外部仓库,对于发现的问题,跟踪纠正预防措施。

Oversight the off-site warehouse periodically, follow up the CAPA for discoverable issue.

  • 监督运输车辆的验证状态。

Oversee the qualification status of cold truck.

  • 参与礼来苏州工厂产品相关的偏差发起、调查、批准。

Participate in Lilly Suzhou site product related deviation initiation, investigation and approval.

  • 参与礼来苏州工厂产品相关的变更发起、执行、批准。

Participate in Lilly Suzhou site product related change initiation, implementation and approval.

  • 确保礼来全球质量体系GQS在本地质量体系中的实施与改进

Ensure GQS implementation and improvement in local quality systems

  • 及时了解与学习GQS的更新文件。

Learn latest version of GQS documentation timely.

  • 通过审核和批准相应部门的SOP和WI,确保相应的流程和操作符合GQS要求。

To ensure the business process and operations meet requirement of GQS through reviewing and approving related SOP and WI.

  • 确保运输要求符合相应的GQS的要求

Ensure that the distribution practice meets the requirements of GQS.

  • 完成成品的转仓确认。

Complete the transfer confirmation of finished product.

  • 做其它和质量有关的事项。

To assume other tasks related to Quality.

  • 根据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 local government regulations.

  • 支持工厂自检以及内外部的审计。

Give the support on self-inspections and internal/external regulatory inspections.

  • 负责起草修改职责相关的SOPs。

To be responsible for drafting and revising the SOPs related to duty.

  • 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.

  • 其他任务由主管安排。

Other tasks assigned by supervisor.

基本要求:

Basic Requirements:

  • 本科及以上学历,药学,化学或相关学科Bachelor's degree or above, majored in pharmaceuticals, chemistry or related sciences

  • 2-3年的GMP生产或QA经验2 to 3 years of experience in GMP production or QA

  • 能用英语听、说、读、写Capable of listening, speaking, reading and writing in English

其他要求:

Additional Preferences:

  • 具有执业药师证的优先考虑。Licensed pharmacist certificate is preferred.

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.

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