[武汉]鼎康（武汉）生物医药有限公司

岗位描述：
? Participate in the daily activities of the QA Department as assigned;
参加质量检查部门的日常活动；
? Work as directed to establish and maintain Quality Systems to ensure the manufacture, testing and distribution processes comply with applicable regulatory requirements;
按照要求进行工作，以建立和维护质量体系以确保生产，测试和销售过程古河适用的法规要求；
? Participate in the execution of the Product Complaint System and assist with product return, withdrawal or recall   activities, as needed;
参与产品投诉系统的执行，并根据需要协助产品退货、撤回或召回；
? Maintain compliance of the Environmental Monitoring and Validation programs, participate in the internal auditing program for company, as required;
保持环境监测与验证计划的合规性,根据需要参加公司内部的审计计划；
? Create and revise Quality Assurance related documents in support of GMP; Provide QA input on GMP Facility and GMP Utilities issues such as qualification/ requalification, changes, maintenance, startups/ shutdown, disaster recovery, etc.
创建和修订与质量保证相关的文件以支持GMP; 提供有关GMP设施和GMP程序问题的质量检查输入，例如资格/变更资格、变革、维护、启动/关闭，灾难恢复等；
? Review and approval of data for determining the disposition of GMP material (raw material, in? process, drug substance, finished product, packaging, labeling and manufacturing components) and the review and approval of documents and data associated with the Stability Program;
审核和批准用于确定GMP材料（原材料、加工、原料药、成品、包装、标签和生产组建）处置的数据，并审核和批准与稳定计划相关的文件和数据；
? Assist QA Document Control in managing the CAPA, Discrepancy and Change Control systems;
协助质量检查文档控制管理CAPA，差异和变更控制系统。
? Assist in hosting regulatory, customer or due diligence inspections. Work closely with all departments, as assigned, to ensure timely responses and follow up of any observations;
协助进行监管，客户或尽职调查，与分配的所有部门紧密合作，以确保及时作出相应并跟踪所有观察结果；
? Identify training needs and organize training interventions to meet quality standards;
确定培训需求并组织培训干预，以达到质量标准；
? Other work arranged by superior leaders;
上级领导安排的其他工作。