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 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.
作为QA现场支持人员, 在项目期间负责支持项目交付过程中的所有活动包括设备确认、EMPQ，CV/SV，APS等，确保项目交付符合所有使用的标准要求。在项目完毕进入商业化生产期间，他/她负责处理所在生产区域的日常问题，如有需要及时反馈给区域QA人员，并执行生产过程的现场质量监管，确保整个生产过程和产品质量得到控制并符合所有适用的标准要求
As QA, He / She is responsible for support all the main activities during the project delivery phase, including equipment verification and qualification, EMPQ, CV/SV, APS ,etc,. ensure the all project deliveries compliance with all applicable standards requirments. During the project phase transition to routine and commercialization afterwards, ensuring that daily problems of the area are promptly addressed as the shift QA function support, and if necessary, escalate to the area QA. He / She will perform on site quality oversight for manufacturing process and ensure all process and product quality are in control and complaint to all applicable standard requirements.
Should have working knowledge of GQS and CQP expectations related to Quality and the activities within their area (EM, Parenteral manufacturing.... etc.)
Should have working knowledge of the operations within their scope. They should be intimately aware of the working procedures and how activities are executed in their area and historical deviations/issues that occurred to better support operations in mitigating future issues and making the appropriate decision when to escalate.
Review/verify IPC and lab release samples and handover to labs.
Review pre-approved quality critical actions, non-coded interventions, personnel grade B sampling, AAMS access and material transfer on the floor.
Qualified as QA observer for Media Fills.
Create or review SOPs / WIs relating to shop floor; Participate in HEP investigations to prevent human errors.
Educating, coaching and ongoing reinforcement to the zero loop and the front-line staff on the quality system requirements (SPV QP, Quality procedures, DI, Compliance Updates).
Serve as coordinator between the floor zero loop and primary loop QA.
基本要求/Basic Requirements:
Adherence to all the safety policies, standards and guidelines.
Be familiar with GMP and relevant regulatory requirements and have good GMP sense.
Minimum 80% of time at shop floor to support daily operations.
Escalate problems to the OPS manager on shift if necessary.
其他要求/Additional Preferences:
Experience in QA, QC, Production, Engineering, Technical Services, or Regulatory is desirable.
Familiar with Chinese regulation is preferred.
Be capable of reading and writing in English is preferred.
其他信息/Other Information:
Work in various areas within the Insulin Cartridge Parenteral Plant.
Ability to work overtime as required.
Shift work required.
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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.
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