(Sr.) QA Specialist - Fume

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.

FUME QA为包装区域提供质量支持，维护质量系统的运作和GMP合规。

The FUME QA provides support to package area, while maintaining quality systems and GMP compliance.

FUME QA主要支持包装区域的FUME和IT部门， 对跟质量相关的偏差调查，变更控制，设计， 建设，设备和计算机系统，文件升版，GMP图纸，验证，试车和确认等提供支持。

The FUME QA primary support to fume and IT function group, providing assistance and guidance in non-conformance investigation, design, construction, equipment and computer systems, change control proposals, procedure revisions, GMP drawings, validations, and commissioning and qualification.

FUME QA 的职责对于保证GMP合规和各种法规审计的准备等至关重要。

The FUME QA position is essential for maintaining GMP compliance and in the preparation for general inspections by various regulatory agencies.

主要职能：

Key Objectives/Deliverables:

• 影响和监督包装区域的设车验证和计算机系统的验证工作

  Influence and oversee the Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV) of GMP assets in package area.

• 用户要求，规范，设计确认，安装确认，运行确认及性能确认方案及报告，工程流程文件以及其他文件的审核和/或批准，确保资产交付过程符合现行GMP，法规及礼来规程要求。
  Review and / or approval of User Requirements, Specifications, Qualification packages, Engineering Flow Documents, and other documentation. Ensure asset delivery process in compliance with current GMP, regulatory and Lilly standards.

• 审核和批准GMP文件和图纸。
  Review and approve GMP documents / drawings.

• 审核和批准计算机系统/自动化系统相关文件，包括但不限于系统验证方案，用户需求，软件需求，测试方案，支持文件及验证报告。
  Review and Review and approve IT /Automation systems related documents include but not limited to System validation plan, URs, SWRs, test protocols, supporting documents and validation summary report.

• 参与系统回顾策略的制定和审核。确保系统的定期回顾并处于验证状态。确保回顾中识别行动项的按时完成。
  Participate in periodic strategy creation and review. Ensure systems are periodic reviewed and in a validation state. Ensue the on-time completion of actions derived from periodic review.

• 确保参与计算机系统验证项目组的成员了解最新的礼来关于计算机验证的要求。
  Ensure team members who involved in Computer system validation activities are kept up to date with the changes to Lilly Corporate CSV requirements.

• 理解数据完整性在验证，日常活动中的要求及实施方式。参与工厂数据完整性策略及评估等相关活动
  Understand data integrity requirements and practice during validation and routine operation. Participate in site data integrity strategy and assessment activities.

• 影响和监督包装区域的维护/校验活动

  Influence and oversee maintenance / calibration programs within package areas, including benchmarking with other sites.

• 确保资产始终处于确认状态，参与维护策略制定及维护活动审核，以及AQM审核。
  Ensure assets maintained in qualified state. Participate in maintenance strategy setup, provide oversight for maintenance activities and asset qualification monitoring.

• 批准关键报警的审计追踪和业务审核。
  Perform approval for critical alarm audits and business reviews.

• 支持包装流程团队的工作， 和包装区域及支持部门进行影响沟通。

  Support process team projects and communicate impact to package areas and associated support groups.

• 教练和指导质量工程的支持工作， 包括工艺知识， 问题解决，项目管理和文件设计。

  Coach and mentor others in aspects of fundamental quality engineering support, include process knowledge, problem solving, project management and documentation design.

• 参与到自检和/或法规检查中。

  Participate in self-led and / or agency inspections.

• 评估任何GMP相关的事件对SISPQ的影响， 对偏差进行初始的定级，支持调查。

  Evaluate potential SISPQ impact for any GMP-related incident, perform initial levelling of non-conformances, and support the investigations.

基本要求：

Basic Requirements:

• 本科及以上学历，药学化学或相关学科
  Associate degree or above, majored in pharmaceuticals, chemistry or related sciences

• 至少1-3年的GMP经验
  At least one to three years of experience in GMP facility

• 完成/维护CSV的培训
  Become / remain certified on CSV (computer system validation)

• 熟练使用电脑系统
  Proficient with computer systems

• 较强的沟通和人际技巧
  Demonstrated strong communication and interpersonal interaction skills

• 能用英语听说读写
  Capable of listening, speaking, reading and writing in English

其他要求：

Additional Preferences:

• 有礼来的偏差管理和变更控制管理的经验
  Previous experiences with Lilly deviation and change control management

• 有GMP生产，工程，QC, QA 或者TSMS的工作经验
  Experiences in Production, Engineering, QC, QA, or TSMS

• 较强的技术写作和书面沟通技巧
  Demonstrated technical writing and written communication skills

• 执业药师优先考虑
  License pharmacist, preferred

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