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更新于 6月30日

QC Manager (MJ001517)

面議
  • 昆明五華區(qū)
  • 5-10年
  • 本科
  • 全職
  • 招1人

職位描述

化學(xué)藥QC液體制劑理化QC微生物QCGMP認證FDA認證EMA認證HPLC、GC、LCMS團隊管理經(jīng)驗藥品項目轉(zhuǎn)移與驗證經(jīng)驗
YOUR TASKS AND RESPONSIBILITIES
  • Ensures appropriate analytical methods are used to assess stability of new products and review methodology study related documents, including but not limited method development report, validation/ verification/transfer protocol/ report, etc.
  • Oversees the analytical development work performed by analytical contractors or CMOs
  • Oversees the analytical stability studies performed by analytical contractors or CMOs
  • Ensures appropriate analytical methods are used to assess stability of new products and review methodology study related documents, including but not limited method development report, validation/ verification/transfer protocol/ report, etc.
  • Ensures stability studies are appropriate to establish the new product
  • shelf-lifes and are performed in compliance with Bayer policies and China regulatory requirements
  • Review the stability results and stability reports for NPDs and confirm/extend post market shelf-lives products, report OOT/OOS and support risk assessment.
  • Provide on-site technical leadership to CMO to overcome, in a fast and efficient manner, analytical and technical challenges
  • Review analytical results and report.
  • Review raw material specifications and ensurecompliance with regulatory
  • Requirements Is responsible to set formulations, raw material and finished product specifications in Product Data Visibility (PDV).
  • Supports CMC documentation draft and review for NPDs, TT projects and post launch change products.
  • Provides on-site support for post launch products, including but not limited impurity study design, method development, pre-validation, lab investigation, informal stability test, etc.
WHO YOU ARE
  • Bachelor's degree in a relevant scientific field (e.g.,Chemistry, Biochemistry, Biotechnology), or international equivalent, with +5 years of prior experience in a technical role within the pharmaceutical or related industry is preferred. Master’s degree or higher with +3 years experience, in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent.
  • Knowledge of regulatory guidelines (e.g., FDA, EMA,CFDA) and industry best practices related to analytical development and stability testing.
  • Knowledge in analytical techniques such as HPLC, GC, LC-MS, dissolution testing, and spectroscopy. Microbiological experience is a plus.
  • Good analytical, problem-solving skills and attention to detail, with the ability to learn and apply new concepts quickly.
  • Good in data analysis software and tools commonly used in the lab field.
  • Good communication and interpersonal skills, with the ability to work effectively in a team environment.
  • Good English communication skills, both written and verbal. Other languages are a plus.
  • Detail-oriented with the ability to maintain accurate documentation and records.
  • Strong desire to learn and grow within the lab field.
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工作地點

昆明五華區(qū)拜耳集團子公司

職位發(fā)布者

劉女士/TA

立即溝通
公司Logo拜耳集團
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)活動來改善人們的生活質(zhì)量。與此同時,拜耳通過突破性創(chuàng)新幫助農(nóng)戶、消費者得到健康、安全、可負擔(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年財富世界500強排行榜中拜耳排名240位。早在1882年拜耳公司進入中國市場,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、健康消費品和作物科學(xué),并運營著多家工廠。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。伴隨著正在進行的一些重大投資項目,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)生喜愛雇主等多個獎項。同時,拜耳也是提供均等機會的雇主。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: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。
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