Lilly QA Specialist in Suzhou-苏州, 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 35,000 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.
负责对LTC 进厂产品进行审核和放行；对可能发生的质量事件或偏差进行深入的调查及原因分析，并采取相应的改进措施，保证产品质量及符合性；维护文件和记录的完整性和准确性，确保符合当地GSP的要求及礼来GQS的要求；Be responsible for imported product verification and batch release, Investigate and/or escalate any quality issues identified or deviations occurred, and perform or assist any quality improvement actions or initiatives to ensure compliance and product quality. Maintain documents/records appropriately, and in full compliance with GSP and Lilly GQS requirement.
日常负责接收后每批的产品物理检查和确认。Mainly be responsible for the product inspection, verification physically after the product receiving into LTC warehouse batch by batch.
及时对产品进行系统放行，包括SAP和WMS系统。Timely batch release after verification both in SAP system and WMS system.
如有任何异常产品情况或可疑假药，及时报告质量经理，并一起进行处理和解决。Timely report and feedback to LTC quality manager if have any issue or suspected countfeit product occurrence, and work with team to handle and manage.
对退货产品进行收货后的确认，并移交质量经理进行判断。Returned product receiving and verification, then hand over to LTC quality manager to justify。
对上传后的电子监管码进行确认。Double check serialization number accuracy while upload to website.
产品运输温度的下载和确认。Product transportation temperature download and verification
维护批放行相关的文件和记录。Maintain documents of batch release and related records
负责可能对产品质量有潜在影响的偏差或事件进行调查和处理，保证偏差或事件的处理符合礼来GQS的相关要求, 并进行纠正、预防措施的有效实施与跟踪。Conduct and manage deviation/events potentially impacting product quality, and ensuring the handling of the deviation/events meets the requirements of Lilly GQS. Effectively follow up the corrective and preventive actions to ensure implementation and completion.
主导或参与质量改进活动，提高质量管理体系，保证仓库整体的符合性，如SOPs的修订，变更控制，及其他项目中相关改进措施的跟进。Lead and/or participate in quality improvement initiatives or CAPA to improve the overall quality systems or compliance of the warehouse. Activities may include SOPs revision, change controls, and other project or system related improvement activities.
本科或以上学历，药学，化学或相关专业, 且至少一年的药品经营管理QA经验和GSP知识背景。Bachelor degree or above, majored in pharmaceuticals, chemistry or related sciences with at least one years of QA experience in drug product distribution/ wholesaler and GSP knowledge background.或满足GSP对于学历的基本要求，具有药学或者医学、生物、化学等相关专业中专以上学历或者具有药学初级以上专业技术职称。且至少3年的药品验收的直接经验和GSP知识背景Graduation from professional technical secondary school in pharmacy or medicine, biology, chemistry, etc. or the professional technical title above the primary level in pharmacy to meet GSP minimum requirement, with at least 3 years’ experience in product verification, batch release in the pharmaceutical industry, and GSP knowledge background.
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At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!