1、負責工廠偏差、變更控制、IATF16949,ISO14001的體系管理,包括行動項的指導和跟進,并提供相關信息和趨勢分析。
Responsible fsite deviation, change control, IATF16949,ISO14001 system management, including the followupguidance faction plan. As well as providing related information trend analysis.
2、負責產品投訴的處理,協調工廠內外部審計,自查以及質量差距評估、產品召回、質量計劃維護、質量系統評審、不良反應等合規(guī)性活動,并提供合規(guī)相關信息和趨勢的分析; 。
Responsible fhandling production complaint, coordinating internal/lexternal audit, the compliance related activitiesike gap assessment, production recall, quality plan maintenance quality svstem manacement review, AdverseDrug Reaction. As well as providing information trend analysis of site compliance.
3、負責維護工廠的文件體系,確保工廠文檔記錄的合規(guī)性以及質量保證團隊中必要的文件起草與修訂審核等。
Responsible fsite document svstem maintenance, ensure the compliance of site documentation the gualityassurance team necessary document drafting revision review.
4、負責維護工廠的培訓體系,確保人員得到相應的培訓并獲得資質,如入職培訓、崗前培訓、年度培訓。
Responsible fsite training system maintenance, ensure that personnel are appropriately trained qualified , such asinduction training, pre-job training, annual training;
5、負責檔案室GMP 文件的管理,包括文件的接收、歸檔、借閱、復印和掃描等。
Responsible fthe archives room GMP documents management, including the documents receiving, archiving.ending, reading, copying scanning.
6、負責法規(guī)指南監(jiān)控與解讀流程的運行與相關業(yè)務的開展。
Responsible fthe operation of the monitoring interpretation process of regulatory guidelines the operation ofrelated businesses:
7、負責組織審核產品生命周期內的質量風險評估、控制、信息交流和回顧評審等系統化過程。如風險評估報告的編號、起草(必要時)、審核以及后續(xù)的文檔管理等。
Responsible fthe systematic process ofganizing reviewing the quality risk assessment, control, informationcommunication throughout the product life cycle.Such as risk assessment report numbering, drafting (ifnecessary), review subsequent document management.
8、負責所有物料相關事宜的質量保證, 以及倉庫日常運作的質量監(jiān)管, 確保工廠的物料、包材、產品和服務符合需求。
Responsible fthe quality assurance of material related activities, monitoring warehouse routine operation. Ensuresite material, packaging material, product service meet the reguirements.
9、領導交代的其他任務等,如:必要時需臨時支援團隊內部現場QA和驗證QA的部分工作。
The tasks assigned by the leader, etc. Such as temporary support fon-site QA validation QA within the team asnecessary.