職位描述
Main responsibilities:
1.Be responsible for the test method creations, validations, verifications and technical transfer of methods for drug substances, in-process drugs and finished products;負(fù)責(zé)原料，中間產(chǎn)品和成品檢測方法的創(chuàng)建、驗證、確認(rèn)和方法的技術(shù)轉(zhuǎn)移；
2.Conduct cleaning validation studies and analyses; 執(zhí)行清潔驗證研究和分析；
3.Prepare, draft or revise SOPs, TMs, QSs, protocols and reports.起草或修改標(biāo)準(zhǔn)操作程序、檢測方法、質(zhì)量標(biāo)準(zhǔn)，方案和報告；
4.Assist the QC Laboratory in conducting the release test for drug substances, in-process drugs and finished products;協(xié)助質(zhì)量控制實驗室原料，中間產(chǎn)品和成品的放行檢測；
5.Create and perform the stability studies for finished products.創(chuàng)建和執(zhí)行成品的穩(wěn)定性研究。
Requirements:
1.Good oral and written english skill (CET-4 or above) 良好的英語技能（CET-4或者以上）
2. Bachelor Degree major in chemsitry or related. 本科學(xué)歷，化學(xué)相關(guān)專業(yè)
3. Around 1-5 years related working experience in Pharmaceutical plant. 1-5年制藥工廠相關(guān)工作經(jīng)驗
企業(yè)介紹
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)專家隊伍，愛美津致力于提供高品質(zhì)產(chǎn)品、有競爭力的價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個簡化新藥被推薦批準(zhǔn)
2014 產(chǎn)品在美國市場上市, 中國市場產(chǎn)品恢復(fù)生產(chǎn)。
2015 通過美國食品藥品監(jiān)督管理局針對數(shù)據(jù)完整性的專項檢查
