[武汉]鼎康（武汉）生物医药有限公司

岗位描述：
? Participate the daily activities of the Drug Product Manufacturing Group.
参加成品药生产部门的日常活动。
? Author documents for drug product manufacturing processes.
编制成品药生产流程文件。
Participate in the internal auditing program as required.
按要求参加内部审核程序。
? Provide input to QA on GMP facility issues and maintain oversight of the Environmental Monitoring and Validation programs.
为QA提供有关GMP设施问题的意见，并对环境监测和验证计划进行监督。
? Anticipate potential problems and take preventative actions and escalate process issues as necessary to ensure resolution.
预测潜在问题并采取预防措施，并根据需要升级流程问题以确保解决问题。
? Review documentation and check all calculations (eg batch records, labels equipment readings).
审核文档并检查所有计算（例如批记录、标签设备读数）。
? Ensure operations strictly adhere to all QA-Controlled documents (such as SOPs, Batch Records) and cGMP/Quality requirements.
确保操作严格遵守所有QA控制文件（例如SOP、批记录）和cGMP/质量要求。
? Escalate process issues as necessary to ensure resolution.
必要时升级流程问题以确保解决问题。
? Ensure GMP training requirements are complete and current.
确保GMP培训要求完整且最新。
? Ensure all work is performed in a safe manner and meets the specifications for each service request.
确保所有工作都以安全的方式执行，并符合各项服务需求规范。
? Apply proper PPE (Personal Protective Equipment) to all work in the facility.

在工厂的所有工作中使用适当的PPE（个人防护设备）。
? Clean and maintain the GMP facility and production equipment.
清洁并维护GMP设施和生产设备。