岗位描述
建立、优化和维护工作相关操作程序，使其符合cGMP法规要求。 Establish, optimize, and maintain work-related operating procedures to ensure compliance with cGMP regulations. 参与偏差调查、变更、客户质量投诉调查，确保纠正和预防措施的有效执行和记录。 Participate in deviation investigation, change control and customer complaint investigation, ensure the effective execution and record of corrective and preventive actions. 批准中间体，原料药和制剂中间体相关的质量的变更。 Approve quality-related changes to intermediate, API and DPI. 中间体和产品放行或拒绝 Release or Reject of Intermediate and Finished Product OOX和不合格品的管理 OOX and Non-conforming management 项目转移文件的管理 Project transfer documents management 批准生产批记录母本和执行批记录审核 Master batch record approval and executed batch record review 质量标准/方法进行批准 Specification/Method approval 制定、批准原辅料、辅料及包材的规格/方法 Develop and approve specification and method for raw materials, auxiliary materials, excipients and packaging materials 批准方法验证/转移文件，分析原始数据的审核 Method validation/transfer approval，raw data review 质量证明的出具 Issue Quality Certificate 审核和批准项目风险评估报告 Review and approve the project risk assessment report 项目跟踪和客户质量协议的执行，传达内部知晓，满足客户期望 Project follow-up and Quality Agreement execution. Share information internally and meet customer expectations. 供应商资质管理及审计 Manage and audit supplier qualification 成品发货文件及标签准备和审核 Prepare and review shipping documents and labels for finished goods 执行产品质量回顾（商业化产品） Perform product quality review (for commercial products) 审核并批准项目相关验证主计划及验证方案、报告 Review validation master plan, validation protocol and report for projects 组织和参与内部审计，确保内部审计（自检）的执行 Organize and participate in internal audits (self-inspections), ensure implementation. 外部审计接待及CAPA的跟踪、执行 Handle external audits, and CAPA tracking and implementation 监督执行数据完整性要求，潜在的数据完整性问题得到调查和评估。 Oversight the execution of data integrity requirements, and potential data integrity issues are investigated and evaluated. 产品召回和退货处理 Recall and Return handling 人员培训和资格认定 Personnel training and qualification IP和安全操作 IP and security operations 完成主管安排的其他工作和任务。 Jobs and responsibilities assigned by the supervisor. 药学或化学相关专业，本科及以上学历。 Bachelor degree or above in pharmacy or chemistry 了解制药生产、检测和质量管理，熟悉GMP相关法规。 Understand pharmaceutical production, testing and quality management, and be familiar with GMP related regulations. 熟练掌握英文 Proficiency in English 计算机技能良好 Good computer skills 职位类别: 社会招聘