Sr. QA Manager - FUME/CSQ/Inspection
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.
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.
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.
Responsible for reviewing the FUME related SOPs and ensure the content comply with the Lilly Standards and cGMP.
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.
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.
Participate in the establishment of the utility PQ program, including the justification of representative sample points and sampling frequencies
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.
Ensure that computer systems are validated and remain so throughout the lifecycle of the system.
Approve Computer System & Automation related documents including but not limited as assessment documents, any remediation plans and validation deliverables.
Provide the Quality subjects expertise during internal/external audits of computer.
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.
Complete other tasks related to QA.
Revise or develop Lilly Suzhou SOPs according to GQS and local government regulations.
Take part in the internal Site Self Inspection /GMP audit for compliance.
Take part in change management, deviation and product complaints.
Bachelor degree or above, majored in pharmaceuticals, chemistry or related sciences
Five to ten years of experience in production technology or QA.
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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