• 招聘类型：社招
• 工作性质：全职

职位描述

• 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

任职条件

Bachelor’s degree or higher in a scientific or healthcare discipline preferred. • Progressive experience in clinical research or clinical operations within the biotech, pharmaceutical, CRO or relevant field • Quality Compliance or Quality Assurance experience (Manager)/ preferred but not mandatory for Associate Manager • Exhibits a strong understanding of methodologies and approaches • Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required. • Regulatory authority inspection experience preferred • Strong written and verbal communication skills

职位要求

• 学历要求：硕士及以上
• 工作经验：无
• 外语要求：英语

公司福利

• 五险一金 
• 晋升空间 
• 法定节假日