Plan and conduct Quality Control Oversight Visit (QOV) and other quality control activities ? Provide advice and support for continuous operation process optimization ? Provide advice and support to operational team in improving compliance with GCP, SOPs and applicable regulatory requirements and guidelines ? Provide support and guidance to operational staff in risk assessment, risk management and CAPA plan; ? Work with operational team and Quality Assurance team to manage quality issue and noncompliance issues ? Inform Line Manager (LM) and Heads of Quality Control, Heads of the related business line and Quality Assurance of quality issues according to SOPs ? Provide support in inspection readiness and audits ? Prepare periodic reports to LM and Heads of Quality Control and to stakeholders on quality related matters as required by the role ? Complete regular QOV trend analysis and provide lesson learned with operational team ? Contribute to specific quality improvement initiatives ? Perform any other tasks as required by the role
base地可选:北京/上海/广州
职能类别: 临床研究员
联系方式
上班地址:静安嘉里中心
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