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(Sr) QA Specialist

Suzhou, China

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Req ID R-10409 Title (Sr) QA Specialist City Suzhou State / Province Shanghai Country 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 39,000 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.

Responsibilities

职责

域QA负责区域的日常监督,支持,对以下活动提供质量指导:偏差调查,变更控制,流程和主记录的升版,验证,批处理,调试和确认,等。 如需要,对其他的区域QA提供支持。区域QA的职能在维护GMP合规和审计的准备过程中意义重大。

The area QA provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedure / master formula revisions, validations, batch disposition, commissioning, and qualification activities. Advise and provide support to other area QA. The area QA position is essential for maintaining GMP compliance and providing support during preparation for inspections.

域QA负责区域的日常监督,支持,对以下活动提供质量指导:偏差调查,变更控制,流程和主记录的升版,验证,批处理,调试和确认,等。 如需要,对其他的区域QA提供支持。区域QA的职能在维护GMP合规和审计的准备过程中意义重大。

The area QA provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedure / master formula revisions, validations, batch disposition, commissioning, and qualification activities. Advise and provide support to other area QA. The area QA position is essential for maintaining GMP compliance and providing support during preparation for inspections.

以下职能主要支持礼来苏州湖东包装工厂,在有资质的情况下可支持苏州其他工厂。

The following objectives mainly related to Lilly Suzhou Pharmaceutical East Lake Packaging, and can support other site in Lilly Suzhou if related qualified appropriate.

  • 在质量问题上,领导,指导并辅导运营和支持部门的人员。

Lead, mentor, and coach operations and support personnel on quality matters.

  • 保证经常在现场监督GMP行为和质量系统的运作。

Ensure regular presence in operational areas to monitor GMP programs and quality systems.

  • 作为QA代表,参与到包装的流程团队中。

As QA representative, active in local process team.

  • 有能力评估并区分发生在流程团队中的偏差/发现项。

Ability to assess and triage deviations / observations that occur within the local process team.

  • 当发生产品相关的问题时(如,内部投诉, 外部投诉调查,等), 能够和支持部门或者外部合作伙伴一起解决问题, 或者为解决问题提供意见。

Work with support teams and external partners to resolve or provide advice on product related issues (e.g., intro company issues, complaints investigation, etc.) .

  • 参与到工厂自检中, 对内部或者外部的审计提供支持。

Participate in self-led inspections and provide support during internal / external regulatory inspections.

  • 能够有效的审核或批准文件,保证满足产品质量的要求(如, 偏差/发现项,流程,技术研究,验证方案,变更和工程文件。

Ability to effectively review or approve documents to ensure quality attributes are met (i.e., deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents).

  • 参与到六西格玛的项目或者工艺流程改进中,支持质量部门和生产区域的效能提升

Participate in Six Sigma Projects to help improve productivity within the local process team or quality organization.

  • 作为QA代表, 支持流程团队的项目和工艺改进。

Support project and process improvement initiatives in the local process team as the QA function.

  • 需要时,支持现场QA的工作。

Be backup of shop floor QA, as necessary.

基本要求:

Basic Requirements:

  • 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

  • 至少3年的生产或QA经验

At least three years of experiences in production or QA

  • 展现出较强的口头和书面沟通和人际交际技巧

Demonstrate strong oral and written communication and interpersonal skills

  • 展现出较强的做决定和解决问题的技能

Demonstrate strong decision making and problem solving skills

  • 拥有并理解生产工艺和质量系统

Demonstrate knowledge and understanding of manufacturing process and quality systems

  • 较强的技术写作和沟通技巧

Demonstrate technical writing and communication skills

  • 能用英语阅读,表达, 倾听和写作

Capable of read, speak, listen and write in English

其他要求:

Additional Preferences:

  • 关注细节

Strong attention to detail.

  • 有SAP, PMX, TrackWise偏差和变更的使用经验

Experience with SAP, PMX and TrackWise Deviation and Change Management processes

  • 执业药师优先考虑

License pharmacist, preferred

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 ( Lilly_Recruiting_Compliance@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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-10409.

Lilly is an EEO/Affirmative Action Employer and 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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