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            更新于 8月4日

            QC Manager (MJ001517)

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

            職位描述

            化學藥QC液體制劑理化QC微生物QCGMP認證FDA認證EMA認證HPLC、GC、LCMS團隊管理經驗藥品項目轉移與驗證經驗
            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.
            隱私保護提示:拜耳深知個人信息對您而言十分重要,并嚴格遵守法律法規,竭力保證您的個人信息安全。如果您投遞簡歷,您的簡歷及其他您主動提供的個人信息將被錄入拜耳招聘系統,敬請知悉。

            工作地點

            昆明五華區拜耳集團子公司

            職位發布者

            劉女士/TA

            立即溝通
            公司Logo拜耳集團
            拜耳是一家全球化創新型企業,在生命科學領域的健康與營養方面具有核心競爭力。拜耳致力于以創新的產品幫助解決當今人類社會所面臨的一些重大挑戰。隨著人類預期壽命不斷延長,人口不斷增長,拜耳通過專注于預防、緩解和治療疾病的研發活動來改善人們的生活質量。與此同時,拜耳通過突破性創新幫助農戶、消費者得到健康、安全、可負擔的食物,并且生產過程對社區、對環境友好。“拜耳:科技創造美好生活”是我們的使命,我們的目標是改善人們的生活質量。拜耳于1863年創立,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部:處方藥、健康消費品和作物科學,并運營著多家工廠。早在1936年拜耳就開始在上海生產阿司匹林,目前本地生產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。“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: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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