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[交流]
【招聘】世界制药企业（疫苗）新建工厂前20强招QC manager
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Principal Duties • Responsible for the testing and release of raw materials, in-process samples containers/closures, packaging materials, toll/contract manufactured products and VI manufactured products. • Determines technical adequacy of the scientific documents and testing methods used within Quality Control. Reviews calculations and testing performed within Quality control. • Responsible for bringing new technology and procedures into QC for optimizing compliance and efficiency. Responsible for Method validation, method transfer validation and transfer of methods to contract testing laboratories. • Prepares and allocates the department budget for Quality Control. • Ensures the proper administration of the BIVI stability program including evaluation of trends/testing at appropriate intervals as per Regulatory commitments. • Responsible for expeditious testing for resolution of product quality complaints and adverse events complaints. • Responsible for improvement of current QC tests and developing new QC tests with R&D to instigate new QC tests needed for new products. • Responsible for the implementation of and adherence to safety guidelines in the QC laboratory. • Responsible for timely and efficient QC testing to meet required schedules. • Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Requirements • High proficiency in statistical analysis, use of specialized computer data bases such as LIMs, Stability, and other relevant computer software programs associated with area of responsibility. Required Skills • Proficiency compliance regulations such as GMPs, GLPs , ICH, SFDA and MOA Special Skills • Must be flexible in that major project plans may require significant change in response to business changes. • Must use influence across all levels to help separate the ‘critical items’ versus ‘nice to have items for capital projects outcome, results, specialization and operational. Required Education • Degree / Education: Master degree in relevant scientific area ( analytical chemistry or other chemistry area, biochemistry, virology or bacteriology) • Major / Focus: Analytical Chemistry, Biochemistry, Virology, Bacteriology. Language Skills & Proficiency • Engilsh:Write/Read/Speak-Good • Chinese: Write/Read/Speak-Good |
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