Eli Lilly and Company

QA Specialist - Material (BB-63417)

Found in: Neuvoo CN

Description:


负责物料供应商管理流程的建立和实施
Be responsible for establishing and implementing material supplier management program
  • 建立和维护供应商管理流程, 确保符合礼来标准和中国GMP要求
    Establish and maintain supply management program to meet requirements of Lilly Standard and Chinese GMP.
  • 按照供应商管理流程要求执行供应商管理活动,包括但不限于:风险评估,定期质量评估,文件和记录维护,偏差和投诉处理,变更评估等
    Implement supply management activities according to supply management program,
    including but not limited to: risk assessment, periodic quality evaluation, document/record maintenance, deviation and complaint handling and change assessment, etc.
  • 负责进厂物料(进口半成品除外)供应商质量协议的起草,维护和更新
    Responsible for preparation, maintenance and updating supplier quality agreement (except for imported semi-finished product) for incoming material.
  • 按照供应商开发计划配合采购团队开发新的供应商。
    Assist procurement team to develop new supplier according to supplier development plan.

  • 负责GMP服务商的管理
  • Be responsible for management of GMP service providers.
  • 管理整个GMP服务供应商项目(评估风险,变更控制, 制定合格供应商清单,定期质量评估,质量协议, 维护记录和文件等)。

Manage the entire provider program (risk assessment, change control , prepare approved vendor list, providers periodic quality review, quality agreement, maintain the records and documentation in GMP Library, etc)
  • 制定供应商活动计划, 根据计划开发新的供应商, 维护已有供应商的质量状态。

Develop GMP service provider management plan, initiate new providers according to scheduled plan, and maintain qualified status of existed providers.
  • 按照总部审计团队的计划协调供应商审计,对供应商进行评估, 依据适用的可接受的标准来推荐合格的供应商或者拒绝供应商。
    To coordinate audits at the providers according to global audit team plan, perform evaluation, having the authority to recommend the approval or rejection of the providers based on the applicable acceptance criteria.
  • 负责对供应商进行投诉并跟踪整改情况, 对供应商进行不定期的访问。
    Responsible for the complaint of vendor and follow up response and action. Perform periodic visit for providers.
  • 与供应商进行有效的沟通。
    Communicate with providers effectively.
  • 做其它和质量有关的事项
    To assume other tasks related to Quality.
  • 根据当地政府的法规要求修改和完善礼来苏州的流程。
    To revise or develop Lilly Suzhou procedures according to local government regulations.
  • 参与公司内部审计。
    To take part in the internal Site Self assessment /GMP audit for compliance.
  • 负责起草修改职责相关的SOPs。
    To be responsible for drafting and revising the SOPs related to duty.
  • 参与偏差调查、变更执行。
    To take part in deviation, change.
  • 确保各部门的操作行为符合政府法规和礼来质量标准的要求。
    To ensure that each department's operation meets the requirements of local government regulations and Lilly standards.
  • 积极参与建设质量文化。
    Engage in building up quality culture.
  • 其他任务由主管安排。

Other task assigned by supervisor.

calendar_today3 days ago

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