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.
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 :
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.
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
计算机系统 : Computer System :
Computer System :
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.
Visual Inspection :
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.
Basic Requirements :
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