職位描述
Job Purpose工作目的
1. The role is responsible for batch document reviewed timely, perform QA oversight in PU, and assure that Products’ production activity complies with Novartis Quality Policy and GMP requirement.
負責(zé)批文件的及時審核，實施現(xiàn)場檢查，并確保生產(chǎn)過程符合諾華質(zhì)量手冊和GMP要求。
Major Accountabilities 主要職責(zé)
Principal Job Objectives 主要工作目標
1. Review Batch Document and records timely and ensure that the following requirements have been met：
及時審核批文件和記錄并確保滿足以下要求：
1） All the necessary checks and tests have been performed. 確保所有必要的檢查和測試已經(jīng)實施。
2） Review QC testing record and confirm that QC report had been approved by coordinators trained in appropriate disciplines and the product quality conforms to specifications.
審核QC檢測記錄并確認QC報告已經(jīng)由培訓(xùn)過的協(xié)調(diào)員批準并確認生產(chǎn)的產(chǎn)品符合規(guī)定的質(zhì)量標準。
3） All necessary production documentation has been completed and endorsed by coordinators trained in appropriate disciplines and confirm that batch manufacturing activities are in compliance with Novartis quality policy, local regulatory and GMP requirements.
所有必要的生產(chǎn)文件已完成且已經(jīng)由培訓(xùn)過的協(xié)調(diào)員核準過, 并確認生產(chǎn)過程符合諾華質(zhì)量手冊、本地法規(guī)和GMP要求；
4） The marketing authorization and the manufacturing authorization requirements for the product have been met for the batch concerned; 確保批次產(chǎn)品符合市場準入要求和生產(chǎn)合規(guī)要求；
5） The principles and guidelines of GMP, as laid down in the guidelines published by HA, have been followed; 確保遵循衛(wèi)生管理部門頒布的GMP原則和指導(dǎo)方針；
6） The principal manufacturing and testing processes have been validated, if different; 關(guān)鍵生產(chǎn)工藝和檢驗方法變更時要經(jīng)過驗證；
7） Any changes or deviations in manufacturing or quality control have been notified and evaluated in accordance with a well-defined system before any product is released; 在產(chǎn)品放行前，任何生產(chǎn)或質(zhì)量控制中變更和偏差需要通過健全的系統(tǒng)來進行匯報和評估；
8） All relevant factors have been considered, including any not specifically associated with the output batch directly under review (e.g. subdivision of output batches from a common input, factors associated with continuous production runs). 審核批文件要考慮所有相關(guān)因素，包括與產(chǎn)品沒有明確關(guān)聯(lián)的因素（例如正常批次的分批，連續(xù)生產(chǎn)批次的影響因素）。
2. Master document updated
主文件的更新
Review master document (E.g.: MBD, MCR and MBR, etc.) timely, and assure that master document complies with requirement of validation protocol, registration file, etc.
及時審核主文件（例如：主文件，主清潔記錄和主批報等），確保主文件符合驗證方案和注冊文件等相關(guān)的要求。
3. Document archived:
文件存檔：
Safely archive relevant Documentation(e.g.: Batch Document, Cleaning Record, Master Batch Document, Master Cleaning Record, etc.）for the prescribed date.
確保質(zhì)量相關(guān)文件(例如：批記錄，清潔記錄，主批文件，主清潔記錄等)安全地在規(guī)定時間內(nèi)均被存檔。
4. QA Oversight:
QA 監(jiān)管:
GMP monitoring, perform the oversight review as shift QA, escalate timely and push correction or follow up related corrective action.
生產(chǎn)GMP現(xiàn)場監(jiān)控，作為倒班QA執(zhí)行生產(chǎn)現(xiàn)場檢查，并及時匯報，推動和跟蹤相應(yīng)的整改活動。
5. Training:
培訓(xùn)：
Complete individual training according to Individual Annual Training Plan, and other training.
根據(jù)個人年度培訓(xùn)計劃完成個人培訓(xùn)和其它培訓(xùn)。
6. Oversee the execution of in-process control
監(jiān)督中間控制的執(zhí)行和評估
1) Understands the related products efficacy, property and test points which should be paid special attention.
Understands information of product quality reflected from test results.
了解各產(chǎn)品特性及測試關(guān)注點，理解中間控制各項測試的原理和目的。理解測試結(jié)果所反映的產(chǎn)品質(zhì)量信息。
2) Review relavant logbook used in IPC.
審核中間控制過程相關(guān)日志。
3) Monitor the operation of in-process control complies with approved test method.
監(jiān)控中間控制操作過程符合批準的方法要求。
7. Other：
其他：
1） Complete CAPA timely which triggered from deviation, internal audit or other external audit.
及時完成由偏差，內(nèi)部審計或其它審計產(chǎn)生的整改措施。
2） Perform change request releted evaluation.
執(zhí)行變更相關(guān)的評估。
3） Provide effective compliance supporting and services to others.
為其他部門提供合規(guī)方面的有效支持和服務(wù)。
4） Assist QA investigation for noncompliance. 協(xié)助 QA進行不合規(guī)方面的調(diào)查 。
5） Give basic training for PU employees as the purpose of RFT of batch document improvement. 提供基礎(chǔ)培訓(xùn)，以提高PU操作人員批文件一次合格率。
6） Attend to any other work related assignment, which may be given by the superior. 完成上級指定的其他工作。
7） Monitor effectiveness of quality systems within the PU.監(jiān)督運營部門質(zhì)量體系的有效性。
Key Performance Indicators 績效考核指標
1. Review batch documents and cleaning record and ensure quality of BD/CR. 審核批文件及清潔記錄，保證批文件及清潔文件的質(zhì)量。
2. Review MBD/MBR/MCR and ensure quality of MBD/MBR/MCR. 審閱主批文件\主批報\主清潔記錄，保證主批文件\主批報\主清潔記錄的質(zhì)量。
3. Perform QA oversight following project time line and push correction or follow up related corrective action. 按計劃對生產(chǎn)過程進行監(jiān)督，推動和跟蹤相應(yīng)的整改活動。
4. Support audit when necessary and ensure no critical or major finding during audit. 在審計中提供必要的支持， 并且確保沒有嚴重或主要發(fā)現(xiàn)項。
Ideal Background 理想的背景
Education:教育
Bachelor degree above本科及以上學(xué)歷
Languages:語言
Fluent in spoken, written, listening and reading English and Chinese中、英文聽、說、讀、寫熟練
Experience:工作經(jīng)驗
2 years’ experience in Pharmaceutical Industry2年以上藥廠工作經(jīng)驗
