QC Manager-Chemistry & Micro
职位描述
职位描述:
Job Responsibilities:
? Supervise the JHL Environmental Monitoring Program to include system implementation, Facility Qualification, on-going monitoring (sampling, testing, trending).
? Provide support within the Quality Control department for the testing and evaluation of environmental monitoring, product, in-process, and raw material samples.
? 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.
? 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.
? Take a lead role in providing guidance and support on failure investigations and resolution of OOS investigations ensuring staff development in this area.
? Ensure that documentation and laboratory processes are in a constant state of regulatory compliance and inspection readiness
? Author/Contribute to CMC sections of Annual Progress Reports and Annual Product Reviews
? 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.
? Proactively use scientific literature and guidelines to solve problems.
? Ensure test methods are qualified/validated to support production of products for clinical or commercial use.
? 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.
? May contribute to sections of regulatory submissions (primarily IND, BLA etc.).
? Ability to recognize, trouble-shoot, and resolve problems with equipment or individual assays.
Job Requirements:
? Bachelor’s degree with 9+ years’ experience in Biotechnology industry in which 6+ years in quality managerial position, Master’s degree with 6+ years’ experience. Or PhD with 4+ years’ experience in biotechnology induction in which 4+ years’ in quality managerial position.
? Thorough knowledge of GMP regulations and documentation.
? Ability to train others in the application of GMP. Ability to manage multi-disciplinary teams.
? Ability to make contributions across departments, and to effectively interact across departments in pursuit of company goals.
? Excellent verbal and written communication skills; able to communicate in English
? Working knowledge of GMP as it relates to Biologics.
? Experience in directing and leading successful quality control laboratory functions to achieve regulatory approval
企业简介
喜康(武汉)生物医药有限公司于2013年6月19日在武汉市工商行政管理局登记成立。法定代表人Jordanov Raco Ivan,公司经营范围包括生物医药的研发、技术转让、技术服务。(上述经营范围中国家有专项规定的项目经审批后或凭许可证在核定期限内经营)等。
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职位发布日期: 2016-12-16