制剂技术转移DP Technology Transfer

理解并遵守公司的政策，尤其是知识产权保护 Understand and comply with company’s policies, particular in IP (Intellectual Protection). 确保日常工作符合EHS要求 Ensure the compliance with EHS

in daily work. 起草及维护制剂车间工艺验证主计划或验证计划 Draft and maintain process validation VMPs or VPs in Drug Product departmen 起草及维护工艺验证管理程序，以确保GMP合规 Draft and maintain process validation management procedures to ensure GMP compliance. 起草及维护制剂车间技术转移管理程序，以确保GMP合规 Draft and maintain drug product workshop Tech Transfer management procedures to ensure GMP compliance. 审核新转移项目的差距分析、风险评估，转移方案以及工艺流程图 Review gap analysis, risk assessment, transfer plan and Process Flow Diagram for new transfer project. 负责跨厂区的后期项目的差距分析、风险评估，项目变更以及转移方案 Be responsible for gap analysis, risk assessment, project change and transfer plan of post-project across site. validation related documentation management. 跨部门合作，确定技术转移细节，解决相关问题 Cross-departmental collaboration to identify Tech Transfer details and resolve relevant issues. 负责建立和维护技术转移知识平台，支持制剂生产工艺优化 Responsible for establishing and maintaining the Tech Transfer knowledge platform. Supporting Drug Product Manufacturing Process Optimization. 支持技术转移相关文档管理，支持技术转移过程中的偏差调查 Supporting Documentation Management for Tech Transfer. Supporting Deviation Investigation during Tech Transfer. Requirements: 本科及以上学历，微生物学、化学、生物技术、生物化学、制药工程等相关专业 Bachelor degree or above, major in Microbiology, Chemistry, Biotechnology, Biochemistry, Pharmacy or other appropriate education. 熟练掌握无菌保障基本知识和GMP法规，具有三年及以上工艺验证等生物制药行业从业经验 Be familiar with basic knowledge of aseptic assurance and GMP regulation. At least three years’ experience in process validation in biopharmaceutical industry. 有一定的团队合作和沟通能力 Team player with good organization and communication skills. 熟练掌握英语听说读写 Proficiency in English skills, including listening, spoken, written and read. 积极主动，高度责任感，自律意识，注重细节，以结果为导向 Pro-active, high sense of responsibility, self-discipline, focus on details and result oriented.