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.
岗位描述：
Position Brand Description:
区域 QA负责区域的日常监督，支持，对以下活动提供质量指导：偏差调查，变更控制，流程和主记录的升版，验证，批处理，调试和确认，等。如需要,对其他的区域 QA提供支持。区域 QA的职能在维护 GMP合规和审计的准备过程中意义重大。
The area QA provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedure / master formula revisions, validations, batch disposition, commissioning, and qualification activities. Advise and provide support to other area QA. The area QA position is essential for maintaining GMP compliance and providing support during preparation for inspections.
主要职能：
Key Objectives/Deliverables:
以下职能主要支持礼来苏州湖东包装工厂。
The following objectives are mainly related to Lilly Suzhou Pharmaceutical East Lake Packaging.
• 在质量问题上，领导，指导并辅导运营和支持部门的人员。
Lead, mentor, and coach operations and support personnel on quality matters.
• 保证经常在现场监督 GMP行为和质量系统的运作。
Ensure regular presence in operational areas to monitor GMP programs and quality systems.
• 作为 QA代表，参与到包装的运营团队中。
As QA representative, be active in packaging local process team.
• 有能力评估并区分发生在运营团队中的偏差。
Be able to assess and triage deviations that occur within the local process team.
• 当发生产品相关的问题时（如：内部投诉，外部投诉调查，等），能够和支持部门或者外部合作伙伴一起解决问题，或者为解决问题提供意见。
Work with support teams and external partners to resolve or provide advice on product related issues (e.g., intro company issues, complaints investigation, etc.) .
• 参与到工厂自检中，对内部或者外部的审计提供支持。
Participate in self-led inspections and provide support during internal /external regulatory inspections
能够有效的审核或批准文件，保证满足产品质量的要求（如：偏差，规程，技术研究，验证方案，变更和工程文件）。
Be able to effectively review or approve documents to ensure quality attributes are met (e.g., deviations, procedures, technical studies, validation protocols, change controls and engineering documents).
• 参与到六西格玛的项目或者工艺流程改进中，支持质量部门和生产区域的效能提升。
Participate in Six Sigma Projects to help improve productivity within the local process team or quality organization.
• 作为 QA代表，支持运营团队的项目和工艺改进。
Support project and process improvement initiatives in the local process team as the QA function.
• 需要时，支持现场 QA的工作。
Be backup of shop floor QA, as necessary.
• 遵守HSE各项管理流程，履行安全生产职责要求
Follow various HSE management procedures and fulfill the work safety responsibilities
基本要求：
Basic Requirements:
•本科及以上学历，药学化学或相关学科
Bachelor degree or above, major in pharmaceuticals, chemistry or related sciences
• 至少3年的生产或QA经验
At least three-year experiences of production or QA
• 展现出较强的口头和书面沟通和人际交际技巧
Demonstrate strong oral and written communication and interpersonal skills
• 展现出较强的做决定和解决问题的技能
Demonstrate strong decision making and problem solving skills
• 理解生产工艺和质量系统
Demonstrate knowledge and understanding of manufacturing process and quality systems
•较强的技术写作和沟通技巧
Demonstrate technical writing and communication skills
• 能用英语听、说、读，写
Capable of listening, speaking, reading and writing in English
其他要求：
Additional Preferences:
• 关注细节
Strong attention to detail.
• 有SAP, PMX, TrackWise偏差和变更的使用经验
Experience with SAP, PMX and TrackWise Deviaiton and Change Management processes
• 执业药师优先考虑
License pharmacist, preferred
• 有可能加班
Overtime may be required
• 有可能在非工作时间支持团队
May be required to respond to operational issues outside of core business hours / days
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.
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