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更新于 1月16日

QA Sr. Expert (MJ003290)

面議
  • 南通啟東市
  • 5-10年
  • 本科
  • 全職
  • 招1人

職位描述

QA檢驗(yàn)QA審核QA認(rèn)證英語口語流利
YOUR TASKS AND RESPONSIBILITIES

  • Provide professional expertise enable quality subject, issues, system in to daily operation and Proactively communicates HSE issues, risks, status
  • Identify opportunities for continuous improvement and the implementation of best practice principles, to enhance quality system performance maturity level
  • Quality initative proposal, implementation to ensuring that performance confirms and beyond established standards
  • Establish lessons learned program to ensure continues improvement and knowledge inherate
  • Driving optimization E2E operation working process (process map) prevent risk occurrence and satisify customers
  • Responsible for regulatory compliance relevant activities, included CMC dossier/variation preparation, file compliance check, regulatory relevant assessment to ensure the product quality, safety and compliance.
  • Build investigation capabilities at shop floor level and enhance the various quality tools used to identify root causes and appropriate CAPAs.
  • Oversight GMP practice & Operation potential risk identification and mitigation via GEMBA, and Lv. Dialogues and Work with business partners to review identified risks for root cause, impact and recurrence, and ensure that relevant line function owners implement mitigation plans. Ensure that issues are escalated to the relevant functions in a timely manner, as needed.
  • Govern GMP Site License management, audit management to ensure compliance.
  • Review/approval procedures (SOP, protocol, Report, Change, etc.)
  • Handle customer complaints, supplier complaints, material status, quality issues etc.
  • Shopfloor capability & culture advancing through. BP establishment, share, training, coach, quality trigger, BBQ, etc.
  • Define and enforce quality gates and criteria that must be met for critical process, eg. Change control, Deviation, Validation/Qualification, Release
WHO YOU ARE

  • Bachelor’s degree or above in Pharmacy or related disciplines.
  • More than 6 years experience in the pharmaceutical industry in a relevant field such as quality, pharmacovigilance or a directly related area, at least 4 years in quality assurance role.
  • Familiar with local/ International GMP and regulations requirements.
  • Soft Skills:
  • leadership / corporation skills. Data analytical, problem-solving, and decision-making abilities.
  • communication, presentation, and interpersonal skills to effectively collaborate with teams Fluent English in written and in reading and spoken
隱私保護(hù)提示:拜耳深知個(gè)人信息對(duì)您而言十分重要,并嚴(yán)格遵守法律法規(guī),竭力保證您的個(gè)人信息安全。如果您投遞簡(jiǎn)歷,您的簡(jiǎn)歷及其他您主動(dòng)提供的個(gè)人信息將被錄入拜耳招聘系統(tǒng),敬請(qǐng)知悉。

工作地點(diǎn)

南通啟東市拜耳醫(yī)藥保健有限公司啟東分公司

職位發(fā)布者

劉女士/TA

立即溝通
公司Logo拜耳集團(tuán)
拜耳是一家全球化創(chuàng)新型企業(yè),在生命科學(xué)領(lǐng)域的健康與營(yíng)養(yǎng)方面具有核心競(jìng)爭(zhēng)力。拜耳致力于以創(chuàng)新的產(chǎn)品幫助解決當(dāng)今人類社會(huì)所面臨的一些重大挑戰(zhàn)。隨著人類預(yù)期壽命不斷延長(zhǎng),人口不斷增長(zhǎng),拜耳通過專注于預(yù)防、緩解和治療疾病的研發(fā)活動(dòng)來改善人們的生活質(zhì)量。與此同時(shí),拜耳通過突破性創(chuàng)新幫助農(nóng)戶、消費(fèi)者得到健康、安全、可負(fù)擔(dān)的食物,并且生產(chǎn)過程對(duì)社區(qū)、對(duì)環(huán)境友好。“拜耳:科技創(chuàng)造美好生活”是我們的使命,我們的目標(biāo)是改善人們的生活質(zhì)量。拜耳于1863年創(chuàng)立,迄今已有150多年的歷史,公司總部位于德國(guó)勒沃庫(kù)森,全球擁有超過10萬名員工。2019年財(cái)富世界500強(qiáng)排行榜中拜耳排名240位。早在1882年拜耳公司進(jìn)入中國(guó)市場(chǎng),至今已經(jīng)超過130年。隨著中國(guó)成為世界上增長(zhǎng)最快的市場(chǎng)之一,拜耳也逐步加大了在這里的投入。拜耳中國(guó)總部位于上海,截至2019年12月底,擁有超過9,000名員工。2019年拜耳在中國(guó)的銷售額超過到37億歐元。拜耳在中國(guó)有三大事業(yè)部:處方藥、健康消費(fèi)品和作物科學(xué),并運(yùn)營(yíng)著多家工廠。早在1936年拜耳就開始在上海生產(chǎn)阿司匹林,目前本地生產(chǎn)在中國(guó)的銷售額中所占比重越來越大。伴隨著正在進(jìn)行的一些重大投資項(xiàng)目,拜耳致力于成為在中國(guó)發(fā)展的主要引擎。多年以來,拜耳作為人們心目中的理想雇主屢獲殊榮,2019年我們榮膺中國(guó)杰出雇主、中國(guó)典范雇主、非凡雇主101、中國(guó)大學(xué)生喜愛雇主等多個(gè)獎(jiǎng)項(xiàng)。同時(shí),拜耳也是提供均等機(jī)會(huì)的雇主。我們尊重并公平對(duì)待他人,不論其宗教、國(guó)籍、民族、文化、性別或性取向,我們重視并弘揚(yáng)多元文化。“敢想|勇為”(Passion to innovate| Power to change)是拜耳的雇主品牌宣言,它概括了拜耳作為雇主的全部特點(diǎn):其工作文化與公司對(duì)目前和未來員工的期望以及對(duì)他們的回報(bào)。
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