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職責(zé)描述： 在這里，你將既能運(yùn)用專業(yè)知識(shí)，又能運(yùn)用各國(guó)相關(guān)的質(zhì)量法規(guī)，成為全面質(zhì)量保證的專家。工作內(nèi)容，包括但不限于： 1. 進(jìn)行SOP中規(guī)定的相關(guān)工作，以及執(zhí)行國(guó)際經(jīng)貿(mào)合作組織、美國(guó)食品藥品監(jiān)督管理局、中國(guó)國(guó)家藥品監(jiān)督管理局等GLP法規(guī)或其它適用法規(guī)規(guī)定的相關(guān)工作。 2. 進(jìn)行機(jī)構(gòu)審查、特別審查、計(jì)算機(jī)化系統(tǒng)審查、供應(yīng)商/承包商審查等，如有必要，進(jìn)行SOP審核。 3. 進(jìn)行基于研究項(xiàng)目的審查，包括方案審查、試驗(yàn)階段審查、數(shù)據(jù)審查、報(bào)告審查和報(bào)告確認(rèn)審查等。 4. 及時(shí)將檢查結(jié)果以書面形式匯報(bào)給機(jī)構(gòu)管理層和專題負(fù)責(zé)人，對(duì)于多場(chǎng)所項(xiàng)目，還需匯報(bào)給主要研究者，主場(chǎng)所質(zhì)量保證負(fù)責(zé)人和分場(chǎng)所管理層及相關(guān)負(fù)責(zé)人（如涉及）。跟蹤預(yù)防糾正措施（如涉及）的實(shí)施。 5. 維護(hù)QA文件。 6. 協(xié)助客戶及法規(guī)機(jī)構(gòu)的審計(jì)。 7. 協(xié)助和建議QA管理層改進(jìn)質(zhì)量體系。 8. 進(jìn)行QA管理層分配的其它工作。 1. Conduct work described in the related SOPs and according to OECD, US FDA and NMPA, etc., GLP guidelines as well as other applicable regulations. 2. Conduct facility inspection, special inspection, computerized system audit, vendor/contractor audit, etc., and review SOP when necessary. 3. Conduct study-based audit; including plan/protocol review, experimental phase inspection, data audit, report audit and report verification etc. 4. Promptly report any inspection results in writing to management and to the Study Director, or to the Principal Investigator(s) and the respective management, when applicable; Follow up implementation of CAPA, when applicable. 5. Maintain QA files. 6. Assist inspections by client or regulatory agency when necessary. 7. Assist and advise QA management on quality system improvement. 8. Conduct the work delegated by QA management. 任職要求： 任職資格 1. 本科及以上，生物、化學(xué)、生物分子學(xué)、醫(yī)學(xué)免疫、藥學(xué)、動(dòng)物等專業(yè)。 2. 有GLP/GCLP QA 經(jīng)驗(yàn)，GLP背景的環(huán)境行業(yè)做過CSV計(jì)算機(jī)化系統(tǒng)驗(yàn)證的，優(yōu)先考慮。 2. 英文4級(jí)及以上，要看英文法規(guī)，寫英文報(bào)告。 3. 良好的書面、口頭表達(dá)能力及團(tuán)隊(duì)協(xié)作能力。 1. BS or MS degree in a science discipline with experience or training in biochemistry, biotechnology, analytical chemistry, chemistry, pharmacy or related disciplines. 2. Be skillful at reading, understanding and writing English documentation. 3. Have good communication skills, both written and verbal, and work in a team-oriented manner.