1、負(fù)責(zé)工廠偏差、變更控制、IATF16949,ISO14001的體系管理,包括行動(dòng)項(xiàng)的指導(dǎo)和跟進(jìn),并提供相關(guān)信息和趨勢(shì)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(fù)責(zé)產(chǎn)品投訴的處理,協(xié)調(diào)工廠內(nèi)外部審計(jì),自查以及質(zhì)量差距評(píng)估、產(chǎn)品召回、質(zhì)量計(jì)劃維護(hù)、質(zhì)量系統(tǒng)評(píng)審、不良反應(yīng)等合規(guī)性活動(dòng),并提供合規(guī)相關(guān)信息和趨勢(shì)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(fù)責(zé)維護(hù)工廠的文件體系,確保工廠文檔記錄的合規(guī)性以及質(zhì)量保證團(tuán)隊(duì)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(fù)責(zé)維護(hù)工廠的培訓(xùn)體系,確保人員得到相應(yīng)的培訓(xùn)并獲得資質(zhì),如入職培訓(xùn)、崗前培訓(xùn)、年度培訓(xùn)。
Responsible fsite training system maintenance, ensure that personnel are appropriately trained qualified , such asinduction training, pre-job training, annual training;
5、負(fù)責(zé)檔案室GMP 文件的管理,包括文件的接收、歸檔、借閱、復(fù)印和掃描等。
Responsible fthe archives room GMP documents management, including the documents receiving, archiving.ending, reading, copying scanning.
6、負(fù)責(zé)法規(guī)指南監(jiān)控與解讀流程的運(yùn)行與相關(guān)業(yè)務(wù)的開(kāi)展。
Responsible fthe operation of the monitoring interpretation process of regulatory guidelines the operation ofrelated businesses:
7、負(fù)責(zé)組織審核產(chǎn)品生命周期內(nèi)的質(zhì)量風(fēng)險(xiǎn)評(píng)估、控制、信息交流和回顧評(píng)審等系統(tǒng)化過(guò)程。如風(fēng)險(xiǎn)評(píng)估報(bào)告的編號(hào)、起草(必要時(shí))、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(fù)責(zé)所有物料相關(guān)事宜的質(zhì)量保證, 以及倉(cāng)庫(kù)日常運(yùn)作的質(zhì)量監(jiān)管, 確保工廠的物料、包材、產(chǎn)品和服務(wù)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(lǐng)導(dǎo)交代的其他任務(wù)等,如:必要時(shí)需臨時(shí)支援團(tuán)隊(duì)內(nèi)部現(xiàn)場(chǎng)QA和驗(yàn)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.