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更新于 1月13日
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Sr.QA Operation Manager (MJ003216)

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

職位描述

QA認(rèn)證QA檢驗(yàn)QA審核GMP體系英語口語流利團(tuán)隊(duì)管理經(jīng)驗(yàn)
YOUR TASKS AND RESPONSIBILITIES

  • Work as QP to perform batch release, ensure release is implemented within leading time.
  • Provide to the site Quality Head and leadership team an overview of the situation in regards of Quality Operations with the level of details and frequency susceptible to enable decision making.
  • Participate in the site level projects as the contact window from Quality Operation in close collaboration with cross-function team internally and externally.
  • Lead the QA operation team co-located at site workshop, QC laboratory, warehouse, and utilities, and timely provide quality comments, in case of deviation happen during production process. As escalation point to lead complex problem shooting in the daily work.
  • Responsible for all site validation programs and coordinate with involved departments to ensure site validation lifecycle management procedures are established and implemented according to Chinese &EU regulations and Bayer CMS requirements;
  • Lead site CAPA system management, including CAPA initiation, follow up and close in time
  • Maintain deviation system to comply with Bayer CMS and cGMP requirements. Ensure deviation investigation is processed, reviewed and approved in a timely manner. Responsible for the deviation and complaint review board meetings.
  • Acquire and maintain knowledge of current local and international regulatory requirements and trends to ensure that expert advice and appropriate technical support on GMP operation activities.
  • Together with Head of Quality to provide direction and assist with making decisions that ensure the efficient operation of the business.
  • Ensure any product quality/supply issues are communicatedtimely to management as required and are remediated appropriately.
  • Continuously find the area of improvement to contribute to savings and productivity.
  • Participate production level meeting and provide feedback from QA perspective.
  • Provide mentoring and coaching to operation QA team.
  • Participate in HSE trainings. Follow operational procedures. Report safety concerns and report safety proposal
WHO YOU ARE

  • Bachelor or above, major in chemistry/pharmacy or other related areas.
  • Experience: 10 years or more working experience within biotechnology or pharmaceutical, minimum 5 years of experience in quality.
  • Strong technical expertise and familiar with China and global GMP regulations
  • Solid experience in people management
  • Fluent English in written and in reading and spoken
  • Preferred to have working experiences in multinational company with strong GMP consciousness.
  • Excellent leadership and communication skills and ability to work in local and global cross functional teams.
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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
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拜耳是一家全球化創(chuàng)新型企業(yè)，在生命科學(xué)領(lǐng)域的健康與營養(yǎng)方面具有核心競爭力。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，人口不斷增長，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)過程對社區(qū)、對環(huán)境友好?！鞍荻嚎萍紕?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，公司總部位于德國勒沃庫森，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)入中國市場，至今已經(jīng)超過130年。隨著中國成為世界上增長最快的市場之一，拜耳也逐步加大了在這里的投入。拜耳中國總部位于上海，截至2019年12月底，擁有超過9,000名員工。2019年拜耳在中國的銷售額超過到37億歐元。拜耳在中國有三大事業(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年我們榮膺中國杰出雇主、中國典范雇主、非凡雇主101、中國大學(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。我們尊重并公平對待他人，不論其宗教、國籍、民族、文化、性別或性取向，我們重視并弘揚(yáng)多元文化?！案蚁雦勇為”（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目前和未來員工的期望以及對他們的回報(bào)。
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