正在寻找WHAT WE'RE LOOKING FOR: 61 本科及以上学历，生物技术、材料、药学类及相关专业；Bachelor's degree or above, majoring in Biotechnology, Materials Science, Pharmacy or related fields; 61 熟悉ISO9001质量管理体系要求；Familiar with ISO9001 quality management system requirements; 61 熟悉GMP 要求或ISO13485质量管理体系； Familiar with GMP requirement or ISO13485 quality management system
资质CERTIFICATIONS: N/A 经验EXPERIENCE: 61 具备2年及以上质量保证或新项目管理的工作经验。At least 2 years work experience in quality assurance or new project management.
胜任工作要求THOSE NECESSARY TO PERFORM THE JOB COMPETENTLY:
胜任工作要求THOSE NECESSARY TO PERFORM THE JOB COMPETENTLY: 61 有一次性耗材的质量管理经验优先；Experience in quality management of single-use product is preferred. 61 有医疗器械、药包材、药品相关的新项目管理经验者优先。Experience in new project management related to medical devices, pharmaceutical packaging materials, and drugs is preferred.
必要资质PREFERRED QUALIFICATIONS:
61 精通Office办公套件（Excel、PPT、Word）；Proficient in Office suite (Excel, PPT, Word). 61 扎实的书面和口头沟通技巧；Solid written and verbal communication skills. 61 具备一定的分析数据的能力；Have a certain ability to analyze data. 61 优秀的英语读写能力；Excellent English reading and writing skills. 61 有良好的沟通能力和团队协作能力，有较强的责任心；Has good communication and teamwork skills, and a strong sense of responsibility. 61 具有质量控制计划制定的能力/经验。Ability/experience in developing quality control plans. 工作描述HOW YOU WILL THRIVE AND CREATE AN IMPACT: 61 新产品导入，制定质量控制计划Involve in NPI projects and responsible for new project quality control plan development. 61 新产品的质量控制*** article and proto type product quality management. 61 协助工艺验证，制定验证质量标准Assist in process validation, develop validation quality standard. 61 新产品灭菌验证管理New product sterilization validation management. 61 新产品/物料保质期研究管理New product/raw material shelf life study. 61 编制产品验证指南Develop product validation guide. 61 新薄膜、管子、接头等物料国产化项目的工厂内部质量支持Quality support inside factory on new sourced localization film, tubing, connectors etc. 61 常规和新物料的资料检查/核查Data/certificate inspection/verification of regular and new components. 61 协助新工厂、新实验室的验证Assist in the validation of new facility and lab.
