QA文件技术员 牡丹江

月薪： 4-6千/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招5人
  • 01-03 发布

职位描述

1. Responsible for the management of copying, issuing, recalling, archiving ，retention，obsoleting、 of all GMP related documents and records.负责所有GMP相关的文件及记录的复印、发放、收回、归档、保管、废止等管理工作。2.Responsible for coordinating training with the marketing group for managing complaints, field alerts, and recalls.负责与营销部协调管理投诉、现场预警及产品召回的记录管理等。3.Manage in a timely manner all failure investigations and maintain failure investigation documentation and logs (e.g., NOE, Non Conformance, OOS, CAPA, Planned Deviations, Vendor Corrective actions).及时管理所有失效调查并维护失效调查文件和台账记录（例如：NOE、不符合报告、OOS、CAPA、计划偏差、供应商纠正措施等）。4.Responsible for escalation of product quality and GMP related incidents to ensure that prompt and appropriate action is taken.负责产品质量和GMP相关事件的上报记录的管理工作，确保采取及时、有效地的措施。5.Review and approve all changes related to quality GMP activities.审核、批准与GMP质量活动有关的所有变更。6.Review and approve all qualification summary reports (QSRs).审核、批准所有确认总结报告（QSRs）。7.Monitor the debarment list and Adverse Event Reporting’s.监督排除清单和药品不良反应报告。8.Prepare, review, implement and maintain Documentation / Archive SOPs.制定、审核、实施并维护文件记录/归档SOP。9.Prepare, review, implement and maintain numbering systems for all document制定、审核、实施并维护所有文件的编号系统。10.Prepare, review, implement and maintain standard formats for all documents.制定、审核、实施并维护所有文件的标准格式。11.Prepare, review, implement and maintain logs for all GMP documents.制定、审核、实施并维护所有GMP文件的台账。12.Maintain all forms for GMP activities.维护所有GMP活动的表格。13.Issue uniquely numbered forms for all activities.为全部活动发放带有唯一编号的表格。14.Create authorized copies and uncontrolled copies of all GMP documents.打印所有GMP文件的授权复印件和非受控复印件。15.Execute the record management assigned by authorized person.实施授权人任命的记录管理。16. Maintains Quality Operations Key box inventory.保管质量运营部的备用钥匙盒。17. Responsible for maintaining the Quality Assurance Document Room:负责维护QA文件室：- Complete and obsolete document, record and filing完成、作废文件，记录归档- Document inventory文件详细目录- Coordination for destruction of documents that have completed their retention period协调销毁已过保存期的文件。18. Provides support to internal Quality Audits.向内部质量审核提供支持。19. Provide support on metrics gathering and assembly for the monthly, quately and annual metrics and reports.帮助收集整合月度、季度、年度的度量报告。20.Complete any other work task assigned by QA Documentation supervisor.完成QA文件主管安排的其它工作任务。 职能类别： 生物工程/生物制药

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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