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Lilly QA Specialist- Area in Suzhou Manufacturing-苏州, China

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.

Basic Requirement:

1) Major in Pharmacy, bioengineering or Chemistry related, bachelor’s degree or above.

2) At least 2 years of relevant working experience in pharmaceutical companies, QA working experience is preferred.

3) With strong excellent communication and coordination skills; have good cooperation and influence skills, and good decision-making capabilities.

Job Description:

1) Responsible for ELM production batch records review, and the release of intermediates materials to ensure the data completeness and accuracy.

2) Responsible for ELM cleaning validation and sterilization validation package review.

3) Support APS as QA observer.

4) As the backup of area QA, be presence on production area, provide oversight of the on-site execution, participates in the daily activities of the process team, participates in the discussion of deviations and changes, coach and develop zero loop QA members, supports process design, validation, and qualification, etc.

5) Participate in self-inspection and regulatory inspections.

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

职位要求:

1) 制药、生物工程或化学相关专业,本科以上学历。

2) 至少2年以上药企相关工作经验,有QA工作经验者更佳。

3) 具有优秀的沟通、协调能力;具有较好的合作和影响能力,以及良好的决策能力。

主要工作职责:

1) 负责ELM生产批记录的审核,中间体的释放, 确保数据完整真实。

2) 负责ELM相关清洁灭菌验证的文件审核。

3) 在培养基模拟灌装期间作为QA观察员对整个过程进行支持和观察。

4) 作为区域QA的back up,常驻在生产一线,监督现场执行,参与工艺流程团队日常活动,参与偏差和变更的讨论,指导并发展QA zero loop,支持工艺设计、确认和验证等 参与自检或法规检查。

5) 参与自检和外部审计。

6) 撰写升版职责内相关区域的SOP/WI。

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 ( LillyRecruitingCompliance@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.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

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