岗位职责: Job purpose 职位目标 85 Manage and guide the quality control department to ensure all activities meet the requirements of regulations 管理和指导QC部门的工作,确保部门的各项活动符合法规要求 85 Familiar with the safety management requirements of the laboratory, responsible for the safety management of the whole laboratory. 熟悉实验室的安全管理要求,负责整个实验室的安全管理工作 85 Aware of and comply with the corporate and local Quality/EHS Manual, Quality/EHS Management System, Quality/EHS Management Policy, Quality/EHS Goals, and applicable laws and regulations as they apply to this job type/position 关注和遵守公司要求的质量、环境健康手册、管理体系和管理政策、目标和该职位的相关的法规要求
Main Responsibilities, Activities, Duties and Tasks 主要工作职责,活动和任务 85 Review and approve standard operating procedures, deviation reports, OOS/OOT investigation reports, and other QC related quality documents 审核并批准标准操作规程、偏差报告、OOS/OOT调查报告和其他QC相关质量文件 85 Be responsible for organizing the test of all raw materials, packaging materials, intermediate products, finished products, process water, and environment monitor 负责组织对原辅料、包装材料、中间产品、成品、工艺用水和环境的监测 85 Be responsible for the management of instruments, reagents, test solutions, standards, reference materials, titration solutions, culture medium, bacterial species, and retention samples 负责对检验用仪器、试剂、试液、标准品、对照品、滴定液、培养基、菌种和留样的管理 85 Be responsible for stability study of products 负责产品的稳定性研究及测试 85 Be responsible for validation and calibration activities related to QC 负责QC相关的验证和计量校验活动 85 Be responsible for coordinating the implementation of projects related to QC 负责协调QC相关项目的实施 85 Be responsible for expense management of QC 负责部门的费用管理 85 Be responsible for providing necessary technical data and support to other departments 负责为其它部门提供必要的技术资料和支持 85 Quality analysis and summary on a regular basis, report to the QC Manager 定期进行质量分析与总结,向QC经理汇报工作 85 Other work assigned by QC Manager QC经理安排的其他工作 任职要求: Education 教育背景 85 Bachelor degree or above in pharmaceutical, chemical or related major 具有药学、化学或相关专业本科以上学历
Professional Experience, Knowledge & Technical Skills 工作经验,知识和硬性技能 85 5 years or above related working experience in laboratory management, familiar with chemical analysis. 5年或以上相关实验室管理的工作经验,熟悉化学分析 85 Familiar with the safety management requirements of the laboratory and related regulations 熟悉实验室安全管理要求及相关法规 85 Good spoken and written English skills 良好的英语口语和读写能力