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Sr. QA Manager - FUME/CSQ/Inspection

Suzhou, China

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Req ID R-12263 Title Sr. QA Manager - FUME/CSQ/Inspection 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.

为公用设施团队,IT及制程自动化团队,以及胰岛素视觉检测区域范围内的活动提供质量监管,内容包括试车及确认,计算机系统验证及其他日常生产活动。确保所有活动符合礼来质量标准及当前GMP要求。

Provide Quality oversight for activities under the scope of Utility Process Team, IT, process automation, and inspection process team, including C&Q activities, maintenance, computer system validation and other routine production activities, to ensure the compliance with the requirements of Lilly standards and cGMP.
 

实施审计过程并对审计过程中存在的缺陷制定行动计划。

Perform audit for execution process and prepare action plans required to address observations resulted from audit.

为FUME,CS和Inspection相关标准提供解读。帮助团队建立独立决策,及FUME /CS /Inspection相关行动运营的能力。
Providing interpretation of applicable regulations and quality standards as they apply to the operation of FUME and CSQA standards. Help the personnel development of the team to be them to be able to take the right decisions and independently run the FUME/ CS/ Inspection activities.

FUME QA:

  • 负责审核FUME方面的SOP,确保符合礼来质量标准以及当前GMP的要求。

Responsible for reviewing the FUME related SOPs and ensure the content comply with the Lilly Standards and cGMP.

  • 确保系统根据礼来质量标准,法规要求确认,并保持其确认状态。

Ensure systems are qualified according to Lilly GQS, applicable regulated requirements, and maintained in a qualified status.

  • 监控Filling区域维护工作的制定和执行。维护策略的开发和制定,包括Job Plan/ FMEAs/ RCM及PM频率制定。

Ensure the establishment and execution of maintenance for Filling. Provide oversight for Maintenance package development and approval, including Job Plan/ FMEAs / RCM / etc.

  • 为洁净设施(包括纯水,注射用水,洁净蒸汽及洁净压缩空气),空调系统提供质量监管。审核并批准相关的试车及确认相关文件,监控日常数据及趋势。

Provide Quality Assurance support to the Clean Utility process team (Purified Water, Water for Injection, Clean Steam, and Pharmaceutical Compressed Air) and HVAC systems. Review and approval of Commissioning and Qualification related documentations for clean utility and HVAC systems. Provide oversight for routine operation and data trending.

  • 参与制定公用设备的性能确认,包括代表性取样点的理由及取样频率的确定。

Participate in the establishment of the utility PQ program, including the justification of representative sample points and sampling frequencies

计算机系统:

Computer System:

  • 确保计算机系统/过程自动化验证遵循礼来总部LQS-302以及相关LQP的要求,并满足法规部门的相关要求。

Ensure Lilly LQS-302 Series Standards & related LQPs are followed appropriately for the validation of computer systems/ process automation, as well as requirements by regulatory agencies.

  • 确保计算机系统/自动化控制已被验证,并处于正常有效运行状态。

Ensure that computer systems are validated and remain so throughout the lifecycle of the system.

  • 批准对计算机系统/自动化过程的相关文件,例如评估文件、纠正计划和验证文件。

Approve Computer System & Automation related documents including but not limited as assessment documents, any remediation plans and validation deliverables.

  • 在对计算机系统/自动化过程控制进行内/外审查时提供质量专业知识。

Provide the Quality subjects expertise during internal/external audits of computer.

Visual Inspection:

  • 确保灯检区域生产和活动符合总部和本地规程要求,包括自动及半自动检查,AQL,缺陷管理,取样送样流程,区域设备及自动化的确认及验证。

Ensure routine production and related activities in compliance with Lilly standards and local requirements, including automated and semi-automated inspection, AQL, defect management, sampling and delivering process, equipment and automation qualification and validation.

完成与其他与质量相关的事项

Complete other tasks related to QA.

  • 根据GQS和当地政府的法规要求修改和完善礼来苏州的SOP
    Revise or develop Lilly Suzhou SOPs according to GQS and local government regulations.
  • 参与公司自检/GMP审计
  • Take part in the internal Site Self Inspection /GMP audit for compliance.

  • 参与变更,偏差以及产品投诉。
  • Take part in change management, deviation and product complaints.

Basic Requirements:

  • 本科或以上学历,药学化学或相关学科

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

  • 5-10年的生产技术或QA经验

Five to ten years of experience in production technology or QA.

  • 熟练使用英语说,写和读

Capable of speaking, writing and read in English in fluency

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-12263.

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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