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 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.
该职位将为生产运营以及设备调试、确认、验证以及胰岛素卡式瓶商业化生产流程的监控等提供质量监督，作为secondary loop QA，为湖东制造的灌装工艺流程提供支持。质量代表需理解全球质量标准（GQS）和通用质量规范（CQP）及如何将其应用于流程团队运营，因此他们有责任监控流程以确保其符合适用的质量承诺。
The position will provide quality support of the manufacturing operations and equipment as well as the commissioning, qualification, validation and monitoring of the commercial manufacturing process for insulin cartridges and serve as secondary loop support for East Lake Manufacturing filling process. The QA Representative is expected to understand the Global Quality Standards (GQS) and Common Quality Practices (CQP) and how they apply to the Process Team operations. As such, they are accountable for monitoring the process to ensure it is in compliance with applicable quality commitments.
主要职能：
Key Objectives/Deliverables:
以下职责包括礼来苏州湖东制造工厂。
Scope of below responsibility includes Lilly Suzhou East Lake Manufacturing site.
为湖东制造所有工艺流程团队（配液、灌装、目视检查）提供sencondary loop QA 支持。
Provide secondary loop QA support across all manufacturing process teams (Formulation, Filling, Inspection) for East Lake Manufacturing.
基于需要，定期参与流程团队活动
Maintain a regular presence and participation on process teams as needed
支持并定期参与生产一线活动
Support and maintain a regular presence on the floor during production activities
担任商业化团队的质量代表，支持技术转移活动、gCR变更的本地实施、技术日程以及其他工厂推动的活动
Serve as the Quality Representative on the commercialization team supporting tech transfer activities, local gCRs, tech agenda and other site and network initiatives
为任何GMP相关的事件评估潜在的SISPQ影响并支持调查
Evaluate potential Quality impact for any GMP-related incident and support the investigations
指导并发展Primary loop 和Zero loop QA
Act as coach and mentor to primary and zero loop QA personnel
复核主要生产记录和批准物料清单
Review master production record and approve BOMs
参与自检和/或官方检查
Participate in self-led and/or agency inspections
可复核和/或审核GMP文件（例如：不符合项，程序，方案，和变更控制）
Be able to review and or red-line GMP documents (example: Non-conformances, procedures, protocols, and change controls)
100%完成个人培训计划
Maintain 100% compliance on Learning Plan
支持工艺设计、确认和验证，包括：
Support the process design, qualification and validation which includes:
Review and / or approval of User Requirements, Technical Specifications, Qualification packages, Process Flow Documents, and other documentation
确保设计、确认、验证文件和记录符合GMP要求Ensuring design, qualification, validation, and documentation is in compliance with GMPs,
如有需要，参与确认的执行，包括工厂接受测试，安装确认，运行确认，性能确认，培养基灌装和工艺验证Participating in qualification execution, including FATs, IQ, OQ, PQ, Media Fills, process validation, as required
评估操作规范是否符合GMP的要求Evaluating proposed operational practices against GMPs
审核和确认验证方案和报告，如工艺验证，设备确认，厂房设施及公用设施系统确认Review and verify validation protocols and reports, such as process validation, equipment qualification and facility & utility qualification.
对操作和支持人员进行质量相关培训Educate operations and support personnel on quality matters
识别并评估新项目对于现有操作带来的可能的质量风险Identify and evaluate the Quality risk of new project activities on current operations
扩展工艺知识，尤其时与笔芯灌装控制策略相关的知识Develop process knowledge, particularly as it relates to the control strategy for cartridge filling
根据全球质量规范（GQS）和本地法规要求，修改或制定礼来苏州标准操作规程文件Revise or develop Lilly Suzhou SOPs according to GQS and local government regulations
基本要求：
Basic Requirements:
遵守所有安全政策，标准和准则。Adherence to all the safety policies, standards and guidelines.
具备较强的口头和书面沟通能力和人际交往能力。Demonstrate strong oral and written communication and interpersonal interaction skills.
具备根本原因分析和解决问题的能力。Demonstrate Root cause analysis/troubleshooting skills.
学士或相当（科学或工程相关优先）Bachelors or equivalent (Science or Engineering related degree preferred)
其他要求：
Additional Preferences:
有生产，工程，质控，质保，技术服务，或法规的经验Experience in Production, Engineering, QC, QA, Technical Services, or Regulatory.
cGMP知识Knowledge of cGMP's
熟悉中国NMPA，EU GMP者优先Familiar with NMPA, EU GMP is preferred
拥有注射剂工厂相关经验优先Demonstrated relevant experience in a parenteral facility is preferred
他信息其：
Other Information:
可能需要加班Overtime may be required.
出于培训或其他相关活动需要，可能需国内及欧洲和/或美国出差May have some travel with China as well as to Europe and / or the US for training or other related activities
该岗位是日班，但可能需要调整以支持日常生产（24/7运行）Position is a day shift role but requires flexibility to adjust schedule as needed to support the routine operation
日常运营期间，需要手机开机以备线下联系和对产线发生的异常事件进行及时响应。During routine operations, will be required to carry a phone for off- shift coverage and respond to operational issues.
手机在周末或公司假日期间要保持通畅Use of phone may be required on weekends and during company holidays.
申请者可能会在注射药物工厂的各种区域工作。由于注射剂工厂存在部分过敏原，在申请这些岗位时，过敏原的流动性要求和暴露量应当被考虑。Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
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