PQS Associate Director

Brief Job Description 工作描述简述 To establish and sustain a culture of regulatory compliance at Wuxi Supply Point that is proactive and professional that meets regulatory requirements, adds value and delivers a competitive advantage to the business. 建立和保持法规规范体系 以符合法规要求 增加价值并为公司业务提供竞争性的优势 Contribute to the QA function in developing / improving quality management system 协助质量部改进质量管理体系 To provide coordination and oversight of functional quality & compliance and improve function ownership of Quality 通过对各部门质量及合规性提供适当的协调和监督 提高各部门质量的主人翁意识 Typical Accountabilities 主要职责 Quality systems management质量体系管理 - Provide coordination and oversight of functional quality & compliance 对部门质量及合规性提供适当的协调和监督 - Lead and coordinate Quality key systems in place , including, but not limited, 组织和协调关键质量体系的运行 包括 但不限于 GMP training GMP培训 Document management 文件管理 QAA management质量保证协议的管理 Change control变更控制 Quality risk management 质量风险管理 Self-inspection自检 Complaint Management 投诉管理 Management review 质量管理回顾 - Continues improvement the quality system management with Lean tools 利用精益工具持续改善质量体系管理 - Lead and support QAF/ site quality continuous improvement project 主导/支持质量部/工厂持续改善项目 - Maintain the good quality culture in site 维护工厂良好的质量文化 Quality Compliance Routine质量法规规范日常事务 - Provide support on quality oversight on Non-PET business at