(Sr./Principal) Associate-QA Batch Release

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Organization Overview:

负责维护湖东制造工厂产品的批放行管理流程并确保按照要求完成产品的放行活动。

Responsible for maintaining ELM site product’s batch disposition program and ensure s are released according to this program.

执行生产过程的现场质量监管，确保整个生产过程和产品质量得到控制并符合所有适用的标准要求。

Perform on site quality oversight for manufacturing process and ensure all process and product quality are in control and complaint to all applicable standard requirements.

Responsibilities:

作为QA代表参与PMX项目

Participant in the PMX project as QA representative

按时参与日常的会议，从质量角度提出必要建议和改进要求

Attend the regular meeting on time, and provide the suggestion from quality

确保PMX项目的实施符合GQS和GMP的要求

Ensure the implementation of PMX complain with GQS and GMP requirement

与质量团队沟通项目中问题并收集、反馈来自质量团队的需求

Communicate the progress of the project within Q group and coordinate the comments from Q if needed

审核所有PMX项目相关的文件

Review all project related documents

Basic Requirements:

作为质量代表参与 SAP项目（不包含来料释放部分）

Quality representative for SAP system (incoming material release process is not included).

作为 质量代表 参与ELM SAP项目，参与SAP流程设计和改进

Participate in Suzhou ELM SAP design and improvement as the role of q uality representative .

作为 质量代表提供物料和产品所需的 QM 主数据

Be responsible for providing master data for semi-finished products or material as SAP q uality representative

负责胰岛素半成品和培养基灌装批次的释放

Be responsible for batch release of semi-finished insulin products and media fill batches

审核所有批释放相关的文件，确保数据完整和真实

To review all batch records and related quality documents , e nsure the data completeness and accuracy

确保最终产品符合中国政府法规和礼来内部要求

Ensure the final product meets the requirements of local government regulation and Lilly standards

作为业务代表参与批记录审核报告项目

Participate in Global Batch Review Report as site business representative .

完成其他和质量有关的任务

Complete other tasks related to Quality.

参与工厂内容的内审或自查

To take part in the internal site self-assessment /GMP audit for compliance.

负责撰写或修改职责范围内的 SOP 或 WI

To be responsible for drafting and revising the SOP or WI related to duty.

参与职责范围内的偏差，变更，审计或投诉活动

To take part in deviation, change, audit and complaint activities related to duty.

Additional Skills/Preferences:

本科及以上学历，药学化学或相关学科

Bachelor degree or above, majored in pharmaceuticals, chemistry or related sciences

1-3 年的生产或 QA 经验

O ne or three years of experience in production or QA

能用英语说，写和读

Capable of speaking, writing and read in English in fluency

遵守HSE程序，如发现有不合适之处，及时与HSE沟通

Follow all HSE procedures, immediately highlight when not applicable or not updated

及时汇报身边的不安全行为和不安全状态

Highlight all at risk conditions and behavior found

主动发现参与到HSE活动中的机会

Proactively find opportunities to be involved in HSE initiatives among the team or in site HSE

Additional Information:

执业药师优先考虑

License pharmacist, preferred.

可能需要前往美国或欧洲出差

Minimal travel but ability for some business trips to the US or Europe

每天工作8小时，周一至周五，可能需要下班后参加同美国或欧洲的电话会议

8 hour work days, Monday through Friday, but the ability to participate on off-hour teleconferences wit h the US and / or Europe.

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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