岗位职责job responsibilities: responsible for qc audit management, coordinating all necessary activities across each team prior to, during and post audit, train and coach sme to continuously improve audit capability in qc 负责qc整体审计管理,协调各团队资源支持审计前准备,审计执行以及审计后的回复及整改跟踪. 培训辅导部门内sme持续提升整体迎检能力 participate in deviation investigation and report review, ensure appropriate capa is in place 参与偏差调查以及调查报告审核,确保合适的纠正预防措施制定,如有必要,支持和客户的沟通 lead or coordinate cross department change control impact assessment, to ensure appropriate impact assessment is performed and mitigation in place prior to change pre-approval, support communication with clients if needed. 负责或者协调跨部门的变更,确保变更在批准前获得充分的影响评估并识别必要的措施,如有需要,支持和客户的沟通 lead or coordinate cross groups/departments deviation investigation, to ensure appropriate root cause is found, impact assessment is through and appropriate actions (capas)are taken 负责或者协调跨团队/部门的偏差,确保根本原因的确认正确 评估全面以及采取了合适的capas analyze quality data to identify adverse trends and/or potential improvement opportunities coordinate with cross department to mitigate the potential risks. 分析质量数据识别不利趋势和潜在改善机会,组织相关部门落实跟踪改善计划和行动 organize regular walk-throughs in qc address findings and rectify issues detected 日常walk through组织,发现项整改 review and approve department level sop(regulatory terms related) 审核批准部门级sop(与法规条款相关的) lead or participate in internal discussions to resolve quality-related issues coordinate cross-team communication organize and facilitate relevant meetings 参与/lead部门内部quality相关问题讨论解决,协调跨团队沟通,相关会议组织协调

任职要求/jobrequirements: 1.master degree or above,project management, pharmacy, chemistry, biochemistry, analytical chemistry or other related discipline. 硕士及以上学历,项目管理、药学、化学、生物化学、分析化学或其他相关专业. 2.more than 8 years working experiences in biotech or bio-pharmathutical companies 在生物技术或生物制药公司有8年以上的工作经验 3.a good understanding of the overall view of drug development process and qc related activities. 对药物开发流程和质量控制相关活动的整体情况有充分了解 4.a thorough understanding of the principles and management of cgmp compliance, and strong quality minds. 对cgmp合规的原则和管理有深入的理解,并具备强烈的品质意识. 5.comprehensive knowledge in fda, ema, nmpa, ich, who technical guideline and usp, eur.p, ch p pharmacopeia. 全面了解美国食品药品监督管理局(fda)、欧洲药品管理局(ema)、国家药品监督管理局(nmpa)、国际协调会议(ich)的技术指南以及世界卫生组织(who)的技术指南,以及美国药典(usp)、欧洲药典(eur.p)和中国药典(ch p)等药典 6.comprehensive knowledge in ind/impd, nda and anda filing. 具备ind/impd、nda和anda申报方面的全面知识 7.english can be as working language for written and spoken communication.