Shanghai,

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:

该岗位作为中国外部制造的成员,需作为主要的质量联系人负责外部合作伙伴的生产相关活动质量监督和支持.支持职能包括批处置和产品测试,验证,变更管理,偏差管理,周期性审核,审计,投诉管理和文件管理.

The position will initially be a member of China External Manufacturing, and will function as the primary Quality Contact for providing quality oversight and support for manufacturing activities associated with external partnerships. The support activities related to batch disposition and product testing, validation, Change Management, Deviation Management, Periodic reviews, Auditing, Complaints Management and Document Control.

Responsibilities:
  • 建立管理外部生产合作伙伴的质量体系
    Create quality systems to manage external manufacturing partners.
  • 确保外部生产合作伙伴及团队自身运作符合GMP和适合的礼来GQS
    Ensure GMP and appropriate Lilly GQS compliance for external manufacturing partners and the team's own operations.
  • 对外部生产合作伙伴实施适当的礼来质量管理,确保产品成功上市.

Implement appropriate Lilly Quality Governance to external manufacturing partners to assure successful products launching with required quality.
  • 参与业务规划,确保有足够的资源来支持合规和业务需求.

Participate in business planning to ensure adequate resources are available to support compliance and business needs.
  • 根据需求,参与产品批释放,验证和偏差相关的问题解决和日常决策.
    Engage in problem-solving and day-to-day decision-making associated with product batch release, validation, and deviations, as needed.
  • 结合适用的质量源于设计的理念,持续地努力减少偏差,投诉和待执行的质量活动.

Incorporate Quality by Design concepts where appropriate and strive to continuously reduce deviation, complaints and open quality actions.
  • 与外部生产合作伙伴的质量领导建立良好的合作关系,共同制定决策权的详细认知.Create a strong collaborative working relationship with the external manufacturing partners' Quality leaders. Jointly develop a detailed understanding of decision-making rights.
  • 与CEM领导合作,建立高凝聚力团队,管理外部生产合作伙伴.

Partner with CEM leader to create a strong cohesive team to manage the external manufacturing partners.
  • 与礼来全球制造和质量人员合作,学习其他地方的最佳做法.

Work with global Lilly manufacturing and quality staff to learn best practices that exist elsewhere.

Basic Requirements:
  • 具有五年以上从事药品生产,技术服务和/或质量管理的GMP相关经验

5+ years GMP experience including roles associated with production support, TS/MS and/or Quality
  • 本科学历化学,生物,生命科学,制药或工程相关专业优先
    Bachelors or equivalent (Chemistry, Biology, Life Sciences, Pharmacy or Engineering related degree preferred).
  • 英语流利

English fluency

Additional Skills/Preferences:

Previous experience working with Contract Manufactures.

Additional Information:

[The items included in this section should include additional items you wish to share about this position. The bulleted list could contain the following:

• Morning

Position on site, but visiting third parities sites (Suzhou)

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-21837.

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.

Shanghai,

Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.
We were founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that meet real needs. More than a century later, we are passionate about building on this precedent in our continued pursuit to make life better for individuals, communities, and the world around us.
Our heritage and our values are the foundation of our promise to unite caring with discovery to make life better for people around the world.
Our mission 
We make medicines that help people live longer, healthier, more active lives.
Our values
Integrity, excellence, respect for people
Our vision 
We will make a significant contribution to humanity by improving global health in the 21st century.

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