職責(zé)描述：1.Develop, implement quality system improvement and evaluate its effectiveness. Ensure human errors are corrected. Determine if the human errors are systemic problem. The expectation is fewer than 10% of all exception reports being attributed to human error. Use DMAIC (Define Measure Analyze Improve Control) process and skills to diagnose and prevent/solve product design and manufacturing process issues.
開發(fā)并實(shí)施質(zhì)量管理體系改進(jìn)，并評(píng)估其有效性。確保人的錯(cuò)誤得到糾正。確定是否人為錯(cuò)誤是系統(tǒng)問題。期望是所有異常報(bào)告少于10％歸因于人的錯(cuò)誤。使用DMAIC（定義測(cè)量分析改進(jìn)控制）工藝和技能，診斷和預(yù)防/解決產(chǎn)品設(shè)計(jì)和制造工藝問題。
2.Provide analytical investigations and develop key performance indicators as deemed appropriate to measure the quality of the product and/or services; the efficiency of the operations, for example turnaround times for completion of OOSs, OOTs, IRs, CAPAs, Complaint investigations, APRs, CRs, DCRs, etc.
提供分析調(diào)查和開發(fā)認(rèn)為適于產(chǎn)品和/或服務(wù)的質(zhì)量度量的關(guān)鍵績效指標(biāo),運(yùn)營效率,例如OOSs、OOTs、IRs、CAPA、投訴調(diào)查、年度質(zhì)量回顧、CRs、DCRs等等周轉(zhuǎn)時(shí)間。
3.Review documentation for completeness and accuracy, Analyze data in support of Right First Time Metric for all documents including attention on complete, accurate documents first time, companywide and generate summary reports.
審核文件的完整性和準(zhǔn)確性,分析數(shù)據(jù)以支持所有文件首次正確原則，包括注意全公司首次文件完整、準(zhǔn)確,并生成總結(jié)報(bào)告。
4.Create written documentation in accordance with USFDA and Chinese cGMP requirements to support product development and manufacturing.
創(chuàng)建符合美國cGMP和中國GMP法規(guī)的書面文件以支持產(chǎn)品開發(fā)和生產(chǎn)
5.Other tasks assigned by superior
領(lǐng)導(dǎo)安排的其他其他任務(wù)

職位要求：
1. Industry experience within a QA/QC department at a FDA-Regulated, Pharmaceutical or other regulated industry. 在遵循FDA法規(guī)、制藥或其他規(guī)定行業(yè)QA/QC部門經(jīng)驗(yàn)
2. Master or Bachelor's degree plus more than 5 years of related work experience with a good understanding of specified functional area, or an equivalent combination of education and work experience.
碩士或?qū)W士學(xué)位，至少5年相關(guān)工作經(jīng)驗(yàn)，能很好地理解的規(guī)定的職能范圍,或同等教育和工作經(jīng)驗(yàn)。
3. Knowledge of manufacturing processes and relevant statistical techniques (Six Sigma, Statistical Process Control (SPC), Word, Excel, power point and Project.
生產(chǎn)工藝知識(shí)和相關(guān)統(tǒng)計(jì)技術(shù)（六西格瑪、統(tǒng)計(jì)過程控制），Microsoft
4. Demonstrated ability to perform multiple tasks and ability to effectively manage conflict.
能夠執(zhí)行多個(gè)任務(wù)，具有能有效控制沖突的能力。
5. Ability to work well in a team and be able to communicate effectively with colleagues, customers and external clients.
團(tuán)隊(duì)中有好的工作能力，能夠和同事、客戶以及外部委托方有效溝通。
6. Professionalism, Ethical, Compliance Mindset 專業(yè)精神，道德和合規(guī)理念

Amerigen Pharmaceuticals is a multinational company with established development and manufacturing platforms aimed at providing high-quality generic pharmaceutical products.
愛美津制藥是一家集研發(fā)和制造于一體的跨國公司，旨在向美國提供高質(zhì)量的仿制藥品。
With pharmaceutical assets and science-based expertise in the United States and abroad, Amerigen is able to provide quality products at competitive prices along with unmatched customer service.
憑借在美國和海外的制藥資產(chǎn)和技術(shù)專家隊(duì)伍，愛美津致力于提供高品質(zhì)產(chǎn)品、有競爭力的價(jià)格和無以匹敵的客戶服務(wù)。
At the end of 2007, Amerigen has successfully completed the acquisition of an oral solid dose manufacturing facility in Suzhou Industrial Park, China and established Suzhou Amerigen Pharmaceutical Co., Ltd.
2007年底，愛美津完成了在中國蘇州工業(yè)園區(qū)的口服固體制劑生產(chǎn)廠的收購，并成立了蘇州愛美津制藥有限公司。
蘇州愛美津制藥的里程碑如下：
2007 蘇州愛美津成立
2008 首次獲得美國法規(guī)文件受理
2009 首次美國食品藥品監(jiān)督管理局上市批準(zhǔn)和常規(guī)檢查
2010 獲得美國食品藥品監(jiān)督管理局的批準(zhǔn)生產(chǎn)大包裝片劑
2012 通過中國食品藥品監(jiān)督管理局再次檢查-新版GMP (2010版)
2013 通過美國食品藥品監(jiān)督管理局檢查- 4個(gè)簡化新藥被推薦批準(zhǔn)
2014 產(chǎn)品在美國市場(chǎng)上市, 中國市場(chǎng)產(chǎn)品恢復(fù)生產(chǎn)。
2015 通過美國食品藥品監(jiān)督管理局針對(duì)數(shù)據(jù)完整性的專項(xiàng)檢查