職位描述
Purpose of the Job 職位目標:
The microbiology professional works as part of a team is responsible for performing quality control testing of insulin products and water for pharmaceutical use. In doing so, the microbiology professional will be responsible for activities related to operating of laboratory equipment, including Isolator, Microseq, LAL, Vitek 2 compact, Autoclave, Microsope, air sampler, particle counter etc. The microbiology professional will also be responsible for implementing methods of analysis previously established at other NN sites.
做為微生物實驗室的一員,微生物專員負責胰島素產品和制藥用水的質量控制。在此情況下,微生物實驗室專員將負責操作實驗室設備,包括:隔離器、基因測序儀、酶標儀、全自動微生物鑒別系統、滅菌鍋、顯微鏡、空氣采樣器、粒子計數器等。微生物實驗室專員也將負責實施已在其他諾和諾德生產廠建立的分析方法。
Main Job Tasks 崗位職責:
1、Perform analysis on samples and report results timely. 執行樣品分析,及時報告結果
2、Investigate out –of-specification (OOS) results and implement corrective actions when required. 當需要時,調查超出標準結果并執行糾正行動。
3、Perform problem solving related to testing of insulin products and water for pharmaceutical use on reruns, non-conformities etc. in QC microbiology Dept. and support cross Dept. problem solving. 解決在質量控制微生物實驗室發生的與胰島素產品檢測及制藥用水檢測的再測試、不符合等問題并支持跨部門的問題解決。
4、Perform and document all work in accordance with GMP, site, and corporate procedures and policies. Write methods of analysis and other operational documents, translate key operational documents from English into Chinese. 所有操作和記錄文件符合GMP、工廠和公司流程政策。編寫分析方法和其他操作文件,將關鍵操作文件的英文版本翻譯成中文。
5、Be familiar with general requirements in Pharmacopeia; Prepare analytical procedure according to Pharmacopeia; Identify the gap of local procedure and Pharmacopeia; Deep understanding of guidelines of Pharmacopeia. 熟悉藥典通用要求;可以按照藥典編撰分析方法;分析現有分析方法和藥典之間的差異;深入了解藥典的指導方針。
6、Train other end users to operate equipment and to execute methods of analysis.培訓其他最終用戶如何操作設備和進行實驗
7、Maintain a safe working environment and work in compliance with all NN and local Chinese safety and environmental regulations. 維護安全的工作環境并且按照所有諾和諾德和中國當地安全和環境法規工作
Professional Experience專業經驗:
1、4-yr (BS) Degree in Microbiology, Pharmacy, or related field. 微生物學、藥學或其他相關領域學科4 年本科教育學士學位
2、Fluent in written and spoken English 良好的英語書寫和溝通能力
3、Minimum 3 years of pharmaceutical QC Lab experience 至少3 年制藥廠質量控制實驗室工作經驗
4、Previous experience with pharmacopoeia methods for water and product analysis is desirable 具有藥典關于水和產品的分析方法的經驗
企業介紹
在諾和諾德,我們致力于改變,通過改變來攻克糖尿病以及其他嚴重的慢性病。
諾和諾德擁有90多年的歷史,是一家始終致力于創新的公司,是糖尿病領域的領先者。在糖尿病領域的經驗也讓我們可以為更多受其他慢性病困擾的人們提供服務,如:血友病、生長激素紊亂和肥胖癥。
公司總部位于丹麥首都哥本哈根,在全球75個國家和地區擁有近4萬名員工(數字截至2015年6月),產品行銷180余個國家和地區。
諾和諾德(中國)制藥有限公司是總部于1994年在華成立的全資子公司,注冊地點座落于天津經濟技術開發區。