Job Description

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.

保证实验室操作规程符合GMP和公司政策并贯彻执行。

To ensure that laboratory control procedures comply with GMP and Corporate policies.

确保实验室微生物及无菌测试的质量体系，准备相关SOP以及培训计划,保证按时完成微生物测试方法验证及方法转移,支持微生物测试设备的安装

To confirm the quality system with Microbiological test in microbiology Lab, preparation of SOPs, Training program. To qualify the test method related to Microbiological/sterility test, method transfer, method verification/validation will be completed on time. And support the equipment qualification relating to test/Sterility test.

要求 Requirement:

• 负责纯化水系统微生物检测如生物负载，内毒素。

Responsible for microbiological analysis for Utility System, e.g., bio burden test, bacterial endotoxin test.

• 负责清洁验证时如生物负载，内毒素，液体粒子，蛋白残留。

Responsible for analysis for system cleaning validation, e.g., bioburden test, bacterial endotoxin test, liquid particulate matter and protein residual.

• 负责纯化水系统微生物检测中细菌和霉菌的鉴定。

Responsible for identification for microorganisms.

• 负责实验室微生物实验室其他相关测试，并确保符合中国GMP和礼来GQS600s的要求

To take responsibility for other Microbiological analysis in microbiological lab and it should be complied with both Chinese GMP and Lilly GQS600s requirement.

• 负责微生物实验室物料的的管理

To Maintain material in micro lab complying

• 负责分析调查（Analytical Investigation and Observation）（可选）

Responsible for analytical Investigation (Analytical Investigation and Observation) complying with GQS604

• 微生物实验室的持续改进

Micro Lab continuous improvement.

• 负责微生物部分的数据真实有效性评估 （可选）

Responsible for data Integrity in Micro.

• 负责变更的执行 （可选）

In charge of change control happened in laboratory.

• 支持设备验证 （可选）

Support equipment qualification.

• 协调组织GQS 600和相关法规要求的合规性评估 （可选）

Coordinate Gap assessment for GQS 600 and related regulatory requirement.

• 接受主管的授权，批准GMP相关的文件（如如实验室释放报告，验证相关方案，稳定性相关方案、统计学相关文件、验证相关方案、药典变化评估表等）（可选）

Delegation from supervisor to approve GMP documents (including Method validation/verification related protocol, Assessment Form for Pharmacopoeia Change etc)

• 根据GMP要求有序，有组织地书写分析报告和其它文件。

To prepare the analytical reports and other documents in order and organized format.

• 支持实验室的日常运行工作

To support routine operation of microbiology lab

• 做其它和质量有关的事项。

To assume other tasks related to Quality.

• 负责起草修改职责相关的检验操作规程，SOPs和WIs

To be responsible for drafting and revising the Test Procedures, SOPs and WIs related to duty.

• 负责实验室日常报告的第二人复核

To be responsible for the routine lab reports second person verification.

• 协助实验室质量体系的持续改进提高和GLIMS系统实施

To assist with lab quality system continuously improvement and GLIMS deployment.

• 负责实验室新进人员的培训

Responsible for fresh analysts’ training.

• *遵守HSE各项管理流程，履行安全生产职责要求。

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

基本要求 Basic Requirement:

• 本科及以上学历，药学生物学或相关学科

Bachelor’s degree or above, majored in pharmaceuticals, biology or related sciences

• 能用英语说，写和读

Capable of speaking, writing and read in English fluently

• 药厂GMP 背景，QC 部门工作经验

Understanding of Good Manufacturing Practices, with previous experience in Pharmaceutical QC

• 强有力的组织能力，制定计划和按时执行计划的能力

Strong organization skills and the demonstrated ability to develop a plan and drive the timely execution.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

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