QC经理
发布时间:2017-11-29

岗位说明:

?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.).

专业要求:

?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

学历要求:药学,生物类等相关专业本科以上学历

1.主要负责建立抗体及蛋白质产?#36820;?#29289;理化学分析、生化活性分析,杂质分析的分析方法开发以及方法学确认。主要分析方法包括:HPLC、CE、有限检测、蛋白?#39318;?#22806;光?#36164;?#21035;、测定水分和渗透压、细菌内毒素检测等

2.负责监督环境监测项目,包括系统确认、设施确认、周期性监测(抽样、测试、趋势分析等);

3.负责为质量控制部门的环境监测,产成品、中控样品以及原辅?#31995;?#26816;测和评价提供技术支持。

4.负责确保质量控制部的流程符合要求,为QC的系统管理(如产品测试、CAPA、实验室OOS调查、稳定性测试、LIMS系?#22330;?#23454;验室设备校准等)提供支持

5.确保实验?#19994;?#25991;档管理和实验室流程管理处于?#20013;?#30340;符合法规要求。

6.确保测试方法的?#34892;?#24615;,以支持产?#36820;?#20020;床或商业使用。

7.负责第三方合作单位或者第三方实验?#19994;?#23457;计,并对新实验室进行评估,确保数据的完整性。

8.协助公司向法规部门(IND, BLA等)提交产品注册资料。




联系方式:[email protected]


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