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.

批处理QA通过有效的质量监督,确保患者的安全和产品的有效.

The batch disposition QA assures patients safe and drug products efficacious through effective quality oversight of the site.

批处理QA负责成品的批处理.在和批次相关的问题上,如:偏差调查,问题解决,或其它的批次处理活动上,批处理QA为流程团队提供指导.

The batch disposition QA is responsible for disposition of finished products. The batch disposition QA provides guidance to process team members for batch related issues, such as non-conformance investigations, issue resolution and other batch disposition activities.

主要职能:
Key Objectives/Deliverables:


  • 执行成品的批处理,确保高质量的产品及时的被释放到市场上.
    Perform batch disposition of finished products to ensure high quality medicine is released to market in a timely manner.


  • 在和批次处理相关的质量问题上,领导,指导或者辅导生产或者支持人员.
    Lead, mentor and coach operation and support personnel on quality matters associated with the batch / batch disposition.


  • 为包装区域提供指导,确保质量系统的有效性,符合GMP要求.
    Provide guidance in package area to ensure effectiveness of quality system and GMP compliance.


  • 为工厂内部自检,外部质量审计,验证以及产品召回等质量管理活动提供支持.
    Provide support to quality management activities, which may include self-inspection, external quality audit, validation, and product recall.


  • 了解持续稳定性考察结果,确保结果符合法规要求和质量标准.
    Understand the results of on-going stability studies to ensure the results meet regulatory requirements and specification.


  • 能够有效的审核或批准文件,保证满足产品质量的要求如:偏差,规程,方案,质量标准,变更控制.
    Be able to effectively review or approve documents to ensure quality attributes are met (e.g., deviations, procedures, protocols, specifications and change controls).


  • 参与到六西格玛项目或者流程改进项目中,提升批处理的效能.
    Participate in Six Sigma project or process improvement initiatives to improve productivity within the batch disposition.


基本要求:
Basic Requirements:


  • 具有药学,化学,生物学或相关专业本科及以上学历.
    Have an educational qualification of an undergraduate course or above in pharmacy, chemistry, biology, or related sciences.


  • 至少5年的QA/QC工作经验
    At least five years of working experience in QA/QC


  • 熟练使用电脑
    Proficiency with applicable computer systems


  • 较强的口头和书面沟通技巧
    Demonstrate strong oral and written communication skills


  • 较强的人际沟通和团队协作能力
    Demonstrate interpersonal skills and ability to work as a team


  • 较强的根本原因分析和解决问题的能力
    Root cause analysis and troubleshooting skills


  • 关注细节,能够维护质量系统的能力
    Demonstrate attention to detail and ability to maintain quality system


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


其他要求:
Additional Preferences:


  • 独立工作或者团队协作解决问题
    Ability to work independently or as part of a team to resolve issues


  • 拥有礼来的偏差管理和变更控制的经验,优先考虑
    Previous experiences with Lilly deviation and change management, preferred


  • 较强的技术写作和沟通技巧
    Technical writing and communication skills


  • 执业药师优先考虑
    License pharmacist, preferred


其他信息:
Other Information:


  • 有可能需要加班
    Overtime may be required


  • 有可能需要在非工作时间协助解决问题
    May be required to respond to operational issues outside of core business hours/days


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-21691.

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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