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薪資面議
工作性質(zhì): 全職 更新日期: 該職位已過(guò)期
專業(yè)要求: 不限 學(xué)歷要求: 本科統(tǒng)招
職稱要求: 不限 性別要求: 不限
年齡要求: 不限 經(jīng)驗(yàn)要求: 8年以上
工作地區(qū): 浙江.金華.義烏 戶口要求: 不限
截止日期: 該職位已過(guò)期 外語(yǔ)要求: 不限
工資待遇: 面議 招聘人數(shù): 若干人
其他福利:
五險(xiǎn)一金 補(bǔ)充醫(yī)療保險(xiǎn) 專業(yè)培訓(xùn) 出國(guó)機(jī)會(huì) 年終獎(jiǎng)金 免費(fèi)午餐 年度體檢 年度旅游 節(jié)日福利 不定期下午茶
制定明確清晰的驗(yàn)證確認(rèn)概念,指導(dǎo)客戶在正確的時(shí)間正確地執(zhí)行測(cè)試,保證項(xiàng)目的順利實(shí)施。
職責(zé)
1.??執(zhí)行GMP咨詢驗(yàn)證及確認(rèn)項(xiàng)目,如:廠房、設(shè)施、設(shè)備、公用系統(tǒng)如空調(diào)系統(tǒng)、水系統(tǒng)、蒸汽系統(tǒng);審核相關(guān)文件?;
2.??審核和執(zhí)行制藥行業(yè)等的工藝驗(yàn)證、清潔驗(yàn)證,和/或?IT驗(yàn)證(如能執(zhí)行IT更佳)?
3.??主導(dǎo)編寫(xiě)GMP相關(guān)的技術(shù)文件,執(zhí)行風(fēng)險(xiǎn)評(píng)估等;?
4.??其他相關(guān)服務(wù)項(xiàng)目的協(xié)助與支持:如制劑及原料藥廠的差距分析,圖紙審核等;
5.??項(xiàng)目談判過(guò)程的技術(shù)支持。
要求:
藥學(xué)、制藥工程、化學(xué)、生物科學(xué)等相關(guān)專業(yè);
7年以上制藥企業(yè)質(zhì)量、生產(chǎn)或工程部門(mén)的相關(guān)工作經(jīng)驗(yàn);
對(duì)制藥行業(yè)的設(shè)施設(shè)備及公用系統(tǒng),在工程和驗(yàn)證確認(rèn)方面有一定的工作經(jīng)驗(yàn);
依照FDA,EU,ISPE,ICH等法規(guī)和指南,熟悉驗(yàn)證要求;
能夠適應(yīng)出差。
Definite??qualification?and?validation?concepts,?guide?customers?to?execute?test?in?right??time?for?keeping?the?smooth?process?of?projects.
Responsibilities:
Execute?GMP?validation?and?qualification??consulting?projects,?including?plant?validation,?facility?validation,?equipment??validation?and?synergic?system?(air?conditioning?systems,?water?systems);??review?the?related?documents;
Review?and?execute?process?validation,?cleaning??validation?and/or?computerized?system?validation?in?pharmaceutical?industry??(can?execute?computerized?system?is?preferred);
Participate?in?drafting?GMP?documents?and??executing?risk?assessment;
Support?and?assist?other?related?services??e.g.?gap?analysis?in?preparations?and?API?compliance?analysis?and?design?review;
To?provide?technical?support?during?business??negotiation.
Qualification:
????????????????????????????????????????????????????????????????????????????????????????????????????????????
Graduated?in?related?fields?such?as?pharmacy,??pharmaceutical?engineering,?chemistry?and?biotechnology;
At?least?7?years?working?experience?in??quality,?production?and?engineering?department;
With?engineering?and?validation?experience?on??facility,?synergic?system?production?is?need;
Be?familiar?with?the?requirements?of??validation?according?to?the?regulations?and?guides?of?FDA,?EU,?ISPE,?ICH?etc.;
Available?for?short?term?business?trip.
加入德恩,預(yù)見(jiàn)更好的人生!Meet?The?Better?You?in?gempex!預(yù)見(jiàn)我們Foresee?Us德恩是一家獨(dú)立的、全球化的服務(wù)供應(yīng)商,專注于為生命科學(xué)行業(yè)提供GMP咨詢與執(zhí)行服務(wù)。公司總部位于德國(guó)曼海姆,并在瑞士錫瑟而恩和中國(guó)廣州設(shè)有分支。德恩總部gempex?GmbH成立于2002年,公司的客戶涵蓋制藥、化學(xué)、生物、化妝品和醫(yī)療器械等領(lǐng)域的領(lǐng)軍企業(yè)。公司專注于提供GMP符合性、確認(rèn)與驗(yàn)證、計(jì)算機(jī)驗(yàn)證和GMP生產(chǎn)相關(guān)的咨詢和項(xiàng)目執(zhí)行服務(wù),服務(wù)范圍從初始階段的分析和概念籌劃到最終實(shí)現(xiàn)。gempex?GmbH?is?an?independent,?international?service?provider?specializing?in?consultancy?and?the?implementation?of?GMP?requirements?in?the?life?science?industry.?Headquartered?in?Mannheim,?Germany,?gempex?also?has?sites?in?Sisseln,?Switzerland?and?Guangzhou,?China.The?company?was?founded?in?2002.Customers?include?leading?companies?in?the?chemical?and?pharmaceutical?industries,?biotechnology,?cosmetics?and?medical?devices.?Services?focus?on?consultancy?and?project?implementation?for?GMP?compliance,?commissioning?&?qualification,?IT?validation?and?GMP?routines.?The?range?of?services?extends?from?the?initial?analysis?and?concept?development?to?their?final?realization.預(yù)見(jiàn)機(jī)遇Foresee?Your?Career我們歡迎充滿激情、專業(yè)、著眼于客戶、注重細(xì)節(jié)、并愿意為德恩以及客戶創(chuàng)造價(jià)值的人才加入我們的團(tuán)隊(duì):We?invite?you?to?bring?your?passion,?expertise?and?customer-oriented?sense?and?explore?career?opportunities?in?your?field?of?interest?to?your?success?at?gempex.What?we?are?looking?for:-高級(jí)GMP?顧問(wèn)?Sr.?GMP?Consultant-GMP顧問(wèn)??GMP?Consultant-?GMP專家?GMP?Expert-?GMP專員?GMP?Specialist預(yù)見(jiàn)未來(lái)的你Foresee?Your?Life@gempex加入德恩,成為我們的一員。在這里,大家雖然個(gè)性不同,但擁有為實(shí)現(xiàn)目標(biāo)而不懈努力的激情,系統(tǒng)培訓(xùn)與個(gè)性發(fā)展是您將在德恩的重要收獲。我們竭誠(chéng)為我們的員工提供富有競(jìng)爭(zhēng)力的薪酬福利、績(jī)效激勵(lì)以及職業(yè)發(fā)展。我們?yōu)槟峁何咫U(xiǎn)一金??商業(yè)保險(xiǎn)?11天帶薪年假?年終獎(jiǎng)金?年度體檢?年度旅游?節(jié)日福利?員工活動(dòng)?不定期下午茶?免費(fèi)午餐Join?gempex,?we?are?an?inclusive?highlighted?by?respect,?collaboration,?open?and?honest?communication?and?diverse?culture.?We?offer?long-term?adventure,?daily?reward,?training?and?opportunity?to?carve?out?a?unique?and?vibrant?career.聯(lián)系我們Contact?us:企業(yè)網(wǎng)址Website:www.gempex.cn企業(yè)微信公眾號(hào)?WeChat:gempexChina
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