Sr. Qa Specialist - Lab

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.

这个职位的设置是作为礼来苏州湖东制造的实验室QA, 是实验室及其工艺团队中的质量代表。他或她将为实验室提供直接的质量监督，以实现可靠、合规的注射剂药品生产。他或她也将为引入不同产品的工艺验证以及内外部的审计准备提供支持。

The purpose of this role is to serve as the Lab QA for Lilly Suzhou East Lake Manufacturing, which will be the QA representative of lab and its process team(s). He / She will provide direct quality oversight to lab to achieve the reliable and compliant manufacture of parenteral drug product. He / She will also support for the preparations for process validation launching of different products and readiness for internal and external inspection
Responsibilities:

• 作为湖东制造实验室的质量代表

Serve as a Quality Representative for ELM Lab
 

• *工艺团队的主要成员，是实验室任何质量话题的联系人

Active member on process team(s) and contact person for any Quality topic in the Laboratory.
 

• 支持工艺设计、确认和验证，包括：

Support the process design, qualification and validation which includes:
 

• 审核和/或批准实验室方法转移和确认相关的方案和包括，和其他文件

Review and / or approval of lab method transfer and verification protocols and reports, and other documentation
 

• 审核和/或批准用户需求，技术标准，确认包，和其他文件

Review and / or approval of User Requirements, Technical Specifications, Qualification packages, and other documentation
 

• 确保设计，确认，验证，操作，规程及文件符合GMP要求，中国GMP，GMP附件1，GSP，LQS/GQS，SOP, 以及其它相应标准

Ensure design, qualification, validation, practices, procedures and documentation are in compliance with GMPs, China GMP, China GMP Annex 1, China Good Supply Practices, Lilly LQS, Lilly GQS, Lilly Suzhou local procedures, and other applicable standards

• 能够审阅或批准重要的GMP文件（例如：不符合项，规程，方案）

Be able to review or approve GMP documents (example: Non-conformances, procedures, protocols)

• 为任何GMP相关的事件评估潜在的Critical Quality Attributes (CQA影响并支持调查, 如有需求，批准调查。

Evaluate potential Critical Quality Attributes (CQA) impact for any GMP-related incident ,support the investigations and approve if needed .

• 对相应的变更进行质量方面的评估，如需要批准相关的变更

Assess the related changes from quality perspective, and approve changes if needed

• *按照本地规程，对实验室活动执行质量监管

Perform QA oversight program for the Laboratory as define in local procedure.

• *对实验室电子系统执行审计追踪审核

    Perform audit trail review of the Laboratory E-System.

• 在质量问题方面给予操作及辅助人员培训
  Educate operations and support personnel on quality matters
   
• 参与自检和/或法规检查

Participate in self-led and/or agency inspections.

• 扩展工艺知识，尤其是与笔芯灌装控制策略相关方面

   Develop process knowledge, in particular as it relates to the control strategy for cartridge filling

• 鼓励质量文化

Encourage a quality culture

• 遵守安全健康环境各项管理流程，履行安全生产职责要求

Follow various HSE management procedures and fulfill the work safety responsibilities.
 

• 具备较强的口头与书面沟通和人际交流能力

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)

Basic Requirements:

• 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者优先

Familiar with NMPA is preferred

• 拥有注射剂工厂相关经验优先

Demonstrated relevant experience in a parenteral facility is preferred

Additional 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 (24/7 operation).

• 日常运行期间，需要手机开机以备线下联系和响应运行事项

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，应当考虑过敏原的流动性要求和暴露量。

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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