QC經理
發布時間:2017-11-29

崗位說明:

?1.Supervise the Company Environmental Monitoring Program to include system implementation,  Facility Qualification, on-going monitoring (sampling, testing, trending).

?2.Responsible for antibody and protein drugs physical and chemical analysis, activity analysis and the analysis method of establishment and validation of impurities (including but not limited to HPLC, CE, limited detection, protein ultraviolet spectrum identification, determination of moisture and osmotic pressure, bacterial endotoxin detection, etc.);

?3.Provide support within the Quality Control department for the testing and evaluation of environmental monitoring, product, in-process, and raw material samples.

?4.Lead, coach and develop the Quality Control Laboratory team, review colleagues’ performance, set and communicate objectives, priorities, metrics, development plans and conduct performance assessments.Lead and manage the laboratory testing for Analytical Chemistry, Biochemistry, Viral & Safety, Technical Services, and Senior Technical staff.

?5.Align with corporate Quality processes and IT systems such as product testing, CAPA, lab investigations, stability testing, LIMS, lab equipment calibration providing support to QC Systems.

?6.Take a lead role in providing guidance and support on failure investigations and resolution of OOS investigations ensuring staff development in this area.

?7.Ensure that documentation and laboratory processes are in a constant state of regulatory compliance and inspection readiness

?8.Author/Contribute to CMC sections of Annual Progress Reports and Annual Product Reviews

?9.Manage performance and development of direct reports providing regularly scheduled feedback throughout the year to ensure achievement of organizational and department goals and a productive environment.

?10.Proactively use scientific literature and guidelines to solve problems.

?11.Ensure test methods are qualified/validated to support production of products for clinical or commercial use.

?12.Identify and interact with outside manufacturers and contract test labs. Provide complete data analysis and be able to drive projects to completion using data generated in the design of new experiments and/or critical assessment.

?13.May contribute to sections of regulatory submissions (primarily IND, BLA etc.).

專業要求:

?1.Master’s degree with 6+ years’ experience. Or PhD with 4+ years’ experience in biotechnology induction in which 4+ years’ in quality managerial position. Medicine, biological analysis, analytical chemistry, biochemistry and other related professional;

?2.Thorough knowledge of GMP regulations and documentation.

?3.Ability to train others in the application of GMP. Ability to manage multi-disciplinary teams.

?4.Excellent verbal and written communication skills; able to communicate in English

?5.Experience in directing and leading successful quality control laboratory functions to achieve regulatory approval

學歷要求:藥學,生物類等相關專業本科以上學歷

1.主要負責建立抗體及蛋白質產品的物理化學分析、生化活性分析,雜質分析的分析方法開發以及方法學確認。主要分析方法包括:HPLC、CE、有限檢測、蛋白質紫外光譜識別、測定水分和滲透壓、細菌內毒素檢測等

2.負責監督環境監測項目,包括系統確認、設施確認、周期性監測(抽樣、測試、趨勢分析等);

3.負責為質量控制部門的環境監測,產成品、中控樣品以及原輔料的檢測和評價提供技術支持。

4.負責確保質量控制部的流程符合要求,為QC的系統管理(如產品測試、CAPA、實驗室OOS調查、穩定性測試、LIMS系統、實驗室設備校準等)提供支持

5.確保實驗室的文檔管理和實驗室流程管理處于持續的符合法規要求。

6.確保測試方法的有效性,以支持產品的臨床或商業使用。

7.負責第三方合作單位或者第三方實驗室的審計,并對新實驗室進行評估,確保數據的完整性。

8.協助公司向法規部門(IND, BLA等)提交產品注冊資料。




聯系方式:[email protected]


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