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.
包装和仓库QA 团队通过对包装和仓库区域有效的监督，保证患者的用药安全和有效。
The Packaging &Warehouse QA team assures patients safe and efficacious products, through effective quality oversight of Package and Warehouse activities.
包装团队负责包装区域的日常监督，对日常活动提供支持和指导，如偏差调查，变更，流程和批记录的升版，验证，批处置，数据管理，试车和确认等。
The team is responsible to provide daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedure and master formula revisions, validations, batch disposition, data stewardship, commissioning and qualification activities.
包装和仓库经理负责管理包装区域的QA人员，负责区域文件的解读和培训，确保包装和仓库活动符合法规的要求。
The Packaging and Warehouse QA manager (PKG & WH QA manager) is responsible for managing the activities of QA staff supporting the package and warehouse areas, with respect to regulatory requirements, procedural interpretation and training, regulatory agency inspections and maintenance of inspection readiness within the area.
包装和仓库QA经理支持QA人员的工作，达成工厂的目标，并保持强烈的质量意识。
The PKG & WH QA manager supports QA personnel serving a specific function to achieve site goals while maintaining a strong quality mindset.
包装和仓库QA经理的职位对于追踪部门的绩效，保证产量，符合部门和工厂目标至关重要。
The PKG & WH QA manager position is essential for tracking department metrics to ensure productivity and alignment with department and site goals.
主要职能：
Key Objectives/Deliverables:
辅导， 教练和/或给员工提供反馈。
Mentor, coach and / or provide feedback to employees.
管理区域的预算， 参与部门计划， 根据区域职责设定业务发展计划。
Manage the area budget, participate in organizational planning, development of business plan for area of responsibility.
展现出跨部门影响力。
Exhibit cross-functional influence.
在HR的协助下，制定团队人员的发展计划和并进行绩效管理。
With the assistance of HR, establish development plans for team members and conduct performance management.
参与到Process团队和Flow团队中。
Participate on the process team and flow team.
有能力有效的审核和/或批准GMP 文件，保证满足质量属性（如，不符合项，规程，技术文件，方案，变更和偏差等）。
Ability to effectively review and / or approve GMP documents to ensure quality attributes are met (e.g., non-conformance, procedures, technical studies, protocols, change controls and deviations).
完成其他的安排的任务。
Complete other duties as assigned.
参与到工厂的自检和法规审计中。
Participate in self-led and / or agency inspections.
确保时常在现场监督GMP活动和质量系统的运作。
Ensure regular presence in areas to monitor GMP programs and quality systems.
有能力解决发生在质量部门的异常事件。
Ability to triage non-conformance that occur within the quality organization.
和礼来的支持团队和外部合作伙伴合作，在质量问题上，提供解决方案或建议。
Work with Lilly support groups and external partners to resolve or provide advice on quality related issues.在Process团队或者Flow团队中，领导和参与精益项目，提高生产力。
Lead or participate in Lean Project to help improve productivity within the local process team or quality organization.
由QA副总监或工厂质量负责人委派批准GMP文件，包括但不限于仅用中文编写的质量标准；湖东包装的中文文件和湖东包装的批记录。
With delegation from Associate QA director or Site Quality Leader to approve GMP documents, including but not limited to Specifications which are written only in Chinese; Documents written in Chinese for East Lake Packaging and Tickets for East Lake Packaging.
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 fulfil the work safety responsibility
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, majored in pharmacy, chemistry or related sciences
至少5年GMP生产或质量经验
At least five years working experience in GMP facility
熟练使用电脑系统
Proficiency with applicable computer systems
较强的口头和书面沟通和人际沟通技巧
Demonstrate strong oral and written communication and interpersonal skills
较强的做决定和解决问题的能力
Demonstrated decision making and problem solving skills
根本原因分析和解决问题的能力
Root cause analysis and troubleshooting skills
能用英语听说读写
Capable of listening, speaking, writing and reading in English
其他要求：写明理想的技能或资质，或者该岗位的优选属性。
Additional Preferences: Indicate any skills or qualifications that are desirable or preferred attributes for the position.
有(礼来的)偏差管理和变更管理的经验
Previous experiences with (Lilly, preferred) deviation and change control process
有生产，QA，QC，TSMS或者法规的工作经验
Experience in production, QA, QC, TSMS or Regulatory is desirable
关注细节
Strong attention to detail
有管理经验
Previous experience in supervision
技术写作和沟通技巧
Technical writing and communication skills
执业药师优先考虑
License pharmacist, preferred.
其他信息：包括履行该岗位所需的工作时间安排（轮班或加班），出差或环境要求。
Other Information: Include any work schedule (shift, overtime), travel or environment requirements necessary for the performance of the position.
可能会加班
Overtime may be required
可能需要在非工作时间支持团队解决问题
May be required to respond to operational issues outside of core business hours and days
少量的出差，包括美国或欧洲的商务差旅需求
Minimal travel but ability for some business trips to the US or Europe
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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