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Sr. QA Specialist - Compliance

Suzhou, China

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Req ID R-25281 Title Sr. QA Specialist - Compliance City Suzhou State / Province Shanghai Country 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.

主要职能

Key Objectives/Deliverables:

  • 确保各部门的操作行为符合本地法规及礼来质量标准的要求。负责维护公司质量合规相关的流程和文件,包括管理评审、工厂合规报告、工厂主文件、质量手册
    To ensure that each department’s operation meets the requirements of local government regulations and Lilly standards. Responsible for maintaining the procedures and documentations relevant to the quality compliance, including management review, site compliance report, site master file, quality manual.

  • 作为差距分析协调员

Take Gap Assessment Coordinator role

  • 负责差距分析评估流程的SOP维护,确保符合总部政策
  • the SOP for Gap Assessment process, compliance with global policy

  • 协调对企业质量标准及本地法规等的评估,跟踪实施公司质量体系以提高法规的符合性的行动
    Coordinate the gap assessment for Lilly Quality Standards and local regulations, follow up actives for compliance improvement

  • 负责维护和更新礼来苏州质量体系负责人和企业质量标准负责人清单

Maintain and update the list for Lilly Suzhou Quality System Owner and Business Owner for Corporate Quality Standard

  • 作为质量计划协调员

Take Quality Plan Coordinator role

  • 负责质量计划流程的SOP维护,确保符合总部政策

Maintain the for Quality Plan process, compliance with global policy

  • 起草年度质量计划并协调批准,跟踪其实施
    Coordinate the site quality plan development and approval and follow up the implementation status

  • 负责工厂变更管理

To be responsible for Change control management

  • 负责变更管理流程的SOP维护,确保符合总部政策和中国GMP要求

Maintain the SOP for change control management process, compliance with policy and China GMP

  • 负责变更管理的管控,例如变更审核会议及在工厂质量领导层会议上汇报指标及趋势分析

Lead Change control management governance, Such as Change control review board and metrics & trend present on site quality lead team

  • 对礼来苏州工厂的员工进行TrackWise

Training the Lilly Suzhou employees of TrackWise

  • 其他与质量管理相关的事项,如:
    To assume other tasks related to QA, such as:

  • 参与协调外部GMP审计和礼来总部质量审计
    To be responsible for coordination of external GMP audit and Global Quality Audit

  • 参与合规性会议的议题收集

Participate in the topic collection of governance meeting

  • 负责对职责相关的礼来质量标准评估以及起草修改职责相关的SOPs
    To be responsible for evaluating Global Quality Standards and drafting and revising the SOPs related to duty

  • 参与偏差调查、变更执行等活动

To take part in deviation investigation, change execution etc.

  • 对其它部门提供改进建议和服务
    To provide good services and recommendations to other departments for improvement

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 pharmaceuticals, chemistry or related sciences

  • 3-5年的生产或QA经验
    Three to five years of experiences in production or QA

  • 能用英语说,写和读
    Capable of speaking, writing and read in English in fluency

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-25281.

Lilly is an EEO/Affirmative Action Employer and 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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