M&S-Sterility Assurance Lead-Beijing

Job title职位名称 : Sterility assurance lead • Location工作地点： Beijing北京   About the job工作职责 We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Sterility assurance lead within our M&S China-BEI Site, will be to making best class medicines with excellent strategies and tools and delivering them to our patients. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main responsibilities职责描述： • Developing and implementing comprehensive sterility assurance and microbiological programs in alignment with the organizational strategy, vision, and objectives 根据组织战略、愿景和目标，制定和实施全面的无菌保证和微生物计划 • Developing and implementing effective strategies and procedures for sterility assurance and microbiology across the organization (environment, water, steam, gas, bio-cleaning, gowning, aseptic processes and practices and industrial supplies, etc.) and Qualification/Validation for processes (microbio strategy) 制定和实施有效的战略和程序,确保整个组织无菌和微生物学（环境、水、蒸汽、气体、生物清洁、更衣、无菌流程和实践以及工业用品等），以及流程认证/验证（微生物战略） • Ensuring the compliance of products and processes with applicable sterility assurance and microbiology regulatory requirements and company quality standards 确保产品和流程符合适用的无菌保证和微生物监管要求以及公司质量标准 • Maintaining a system to ensure sterility assurance and microbiological risks are properly identified, tracked and mitigated 维护系统，确保正确识别、跟踪和缓解无菌保证和微生物风险 • Overseeing of production activities as (MFT, best aseptic practices ....) 监督生产活动（MFT，最佳无菌实践......） • Overseeing, with Q&V team, the validation, qualification, and monitoring of methods, equipment, and the environment ensuring sterility assurance control 与 Q&V 团队一起监督方法、设备和环境的验证、确认和监控，确保无菌保证控制 • Following metrics and monitoring data for the sterility assurance and microbiological activities to identify trends and issues and to implement action plan 遵循无菌保证和微生物活动的指标和监测数据，以确定趋势和问题，并实施行动计划 • Establishing and monitoring key performance indicators (KPIs) and metrics for the sterility assurance and microbiological activities and reporting on its performance and effectiveness 建立和监控无菌保证和微生物活动的关键绩效指标（KPI）和指标，并报告其性能和有效性 • Promoting a culture of quality throughout the organization 在整个组织内推广质量文化 • Identifying and driving continuous improvement initiatives and projects to enhance the sterility assurance and microbiological activities 确定并推动持续改进计划和项目，以增强无菌保证和微生物活动 • Evaluating and recommending new technologies, tools, and methods to enhance sterility assurance and microbiology 评估和推荐新技术、工具和方法，以增强无菌保证和微生物学 • Leading management reviews to assess the effectiveness of the sterility assurance program and microbiological program 领导管理层审查，以评估无菌保证计划和微生物计划的有效性 • Leading and managing the sterility assurance and microbiology team, including hiring, training, coaching, professional development, and performance evaluation 领导和管理无菌保证和微生物学团队，包括招聘、培训、辅导、职业发展和绩效评估 • Interacting with external bodies and Global Quality to bring knowledge and awareness of best industry practices (Congress, CoP and CoE) 与外部机构和全球质量部门互动，以提升对最佳行业实践（Congress、CoP 和 CoE）的知识和认识 • Preparing and participating in regulatory inspections and audits, providing expertise on sterility assurance and microbiology 准备并参与监管检查和审计，提供无菌保证和微生物学方面的专业知识 • Providing support for the successful collaboration between Digital, Quality, and technical functions to achieve desire