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3-4年经验 -
大专 -
招1人 -
03-06 发布
职位描述
- 负责产品注册，再注册及补充申请等。负责对注册产品的风险分析，制定注册方案。包括注册文件的准备、文件和样品的递送，及其他相关工作；Be responsible for product registration, renew and supplementary registration. Responsible for regulatory related risk assessment. Including dossier preparation, document and samples delivery and other related job; - 负责法规及客户相关文件的归档、维护与更新；Be responsible for filing, maintaining, and updating documents, including regulatory license, customer quality agreement and specification - 负责收集，更新和评估与公司业务相关的药政及药事法规；评估外部法规对公司的影响，使公司的行为符合法规要求。Collect and update the regulatory regulations related with company business;Evaluated regulation influence to company to assure company compliance with regulation. - 负责对客户提供法规支持，负责填写与法规有关的客户问卷，根据客户或总部要求提供支持性文件；Responsible to provide compliance support to customer include the preparation of questionnaire, supportive documents based on customer, regulatory or global requirement - 协助其他客户相关的法规或客户审计工作Assist in other customer or regulatory related job, including internal audit, third party audit, supplier audit, et al. - 负责ISO9001， Halal, Kosher 证书的年度审核。Responsible for year audit of ISO 9001, Halal and kosher certification.- 在本职工作或是管理区域中维持良好的符合EHS要求的工作环境和安全操作，确保持续符合总部的EHS标准和当地的法律法规要求Responsible for maintaining sound EHS working conditions, practices in your assigned job or area and ensure continuous compliance toEHS Standards and local law requirements 职能类别： 药品注册 关键字： 药品注册 注册专员
联系方式
苏州工业园区苏雅路388号新天翔广场B栋
公司信息
苏州创思特管理咨询有限公司，09年成立于美丽的园林城市苏州，是由数名１０年左右有全球知名猎头公司背景的资深顾问携手创办的专业高端人力资源咨询公司。公司严格控制成长规模和速度，定位于专注、精准，以实现在最大程度上针对现有客户的100%的真诚服务
