质量审计专员 牡丹江

月薪： 3-6千/月

该公司所有职位
  • 1年经验
  • 招1人
  • 生物医学工程 制药工程
  • 01-02 发布
  • 五险一金
  • 免费班车
  • 专业培训
  • 绩效奖金
  • 年终奖金
  • 定期体检
  • 免费公寓

职位描述

1. Responsible for the site quality audit program. Includes maintain SOPS, site annual scheduling, monitoring and follow up to audit findings and completion of commitments。负责现场质量审计活动，包括维护SOP,制定现场年度审计计划、监督、跟踪审计结果和任务完成情况。2. Responsible for the Supplier quality audit program to include supplier qualification ，supplier’s approved list, and annual product monitoring program.参与供应商管理程序包括供应商确认、供应商批准清单和年度产品监控程序。3. Ensures compliance with established internal control procedures by examining records, reports, operating practices, and documentation.通过审查记录、报告、实际操作及文件纪录情况，确保符合已建立的内部控制规程。4. Participate on Vendor Corrective Action (VCAR) Plans and maintain the monitoring of the VCAR system.参与供应商纠正措施(VCAR)计划并对VCAR系统进行监控。5. Completes audit work papers by documenting audit findings. Maintain files generated from each audit.通过记录审计结果完成审计文件,并维护此文件。6. Appraises adequacy of internal control systems by completing audit questionnaires.通过完成审计调查问卷，评估内控体系是否得当。7. Maintains internal control systems by updating audit programs and questionnaires; recommending new policies and procedures.通过对审计活动和调查问卷进行更新，维护内控体系，推荐新程序和流程。8. Communicates audit findings by preparing a final report; discussing findings with auditees.通过编写最终报告告知审计结果，和被审计方就审计结果进行讨论。9. Complies with federal, state, and local security legal requirements by studying existing and new security legislation; enforcing adherence to requirements; advising management on needed actions.通过学习现有和新的安全法规，遵守（美国）联邦、州和地方法规的要求并强制执行；对需要采取的行动提供管理建议。10. Prepares special audit and control reports by collecting, analyzing, and summarizing operating information and trends.通过收集、分析和总结运行数据和趋势，准备特种审计和控制报告。11. Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.通过参加培训研讨会、研读专业文献、建立人际网络、参加专业社团，保持专业技术知识水平。12. Provides internal communication regarding compliance issues and applicable regulation changes.合规性问题及适用法规出现变化时，与内部进行交流。13. Aids in the creation of gap analysis to any new/changed regulations.在新/修订法规引起差距分析时，提供帮助。14. Work with the departments audited to resolve compliance issues, provide recommendation, communication on status of action resolution and bringing to management issues that require attention tracking corrective actions.与接受审计的部门合作解决合规性问题，并提出建议、沟通解决行动的状态，将需要留意跟踪的纠正问题上报于管理层。15. Participate on Vendor Corrective Action (VCAR) Plans and maintain the monitoring of the VCAR system.参与供应商纠正措施(VCAR)计划并对VCAR系统进行监控。16. Complete any other work task assigned by Quality Assurance Manager.完成质量保证部经理分配的其他工作任务。 职能类别： 药品生产/质量管理

联系方式

海林市海林经济开发区东旭路7号

公司信息

公司总部位于美国加利福尼亚州圣地亚哥，生产工厂位于中国东北部风景优美的黑龙江省。基纳瑞克斯提供包括技术转移、工艺开发、放大实验、设备/工艺验证，配液、灌装、冻干、检验、完整性检测、贴标签及装盒等的整套服务，符合美国食药监局、欧洲药品管理局、中国食药监局及日本法规机构的要求。With our corporate headquarters located in San Diego, California, USA and our manufacturing facility located in the scenic Heilongjiang Province in the north eastern part of China OncoGenerix offers a fully integrated suite of services including technical transfer, process development, scale-up, equipment / process validation, formulation, filling, lyophilization, inspection, integrity testing, labeling and cartoning meeting the requirements of the US FDA, EMA, CFDA & Japan Regulatory

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