M&S-Sterile Compounding Expert-Beijing

Job title职位名称 : Sterile Compounding Expert无菌配制专家 • 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 Sterile Compounding Expert 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： Please indicate here the main job responsibilities请列举该职位的主要工作职责。 Generic 通用 1.    Continuously improve the compliance level of sterile production, attend and promote SMS execution, Lean manufacturing. 不断提高无菌生产的法规符合性和质量保证水平，参与并推进赛诺菲制造体系的深度实施和部门的精益生产。 2.    Organize, coordinate, track and implement of deviations, changes, validation, complaints and global standards gap analysis etc. 组织、协调、跟进和实施偏差、变更、验证、投诉以及总部标准差距分析。 3.    To ensure the continuous process compliance improvement through the management of quality systems. 通过质量体系的管理确保生产工艺合规的持续改进。 4.    To ensure the implement of quality policy/objectives of Sanofi and to ensure the quality compliance of sterile production operation. 贯彻执行公司的质量方针和质量目标，确保无菌生产运营的质量合规性。 5.    To ensure effectiveness of sterile production quality improvement programs/projects. 确保无菌生产运营的质量改进计划或项目的有效性   KEY ACCOUNTABILITI关键职责 • Lead continuous improvement work on sterile compounding PCU. • Organize, coordinate, track and execute sterile compounding related investigation of deviations, complaints and correction actions, keep close communication with quality to improve the investigation compliance level. • Participate in and lead sterile production related changes, guarantee the change compliance through regulation understanding. • Establish and assure a continuous GMP training to maintain an high level of GMP awareness in all the staff.  • Be familiar and enhance global standards understanding, lead sterile production related gap analysis and implementation. • undefined • Coordinate the validation execution of process, equipment, cleaning and execution according to the master plan. • Monitor production environment, process, hygiene, facilities and personal behaviour and make proposal for improvement, to make sure the activities comply with SOP requirements， • Lead and coordinate department resource to attend self-inspection, authorities’ inspection and global quality audit. • Manage procedures to correct deviations and out of specification results and monitor the corrective and preventive actions (CAPA) to prevent the repetition of the not compliance instance. • Ensures quality risks are properly managed (identification, assessment, control, communication).  • Assure the correct handling of product recall and customer complaints. • Ensure effectiveness of gap analysis process. • Involve site quality improvement projects/programs (compliance program, QMI, DIMM etc) to ensure the effectiveness of project/programs. • Participate in process optimization, equipment improvement and technique innovation to sustainably improve OEE and yield, participate in SMS standards deep execution and continuously improve in 5S/HSE aspects and waste minimization. • Other tasks temporarily assigned by department manager. •  Sterile production Department HSE Responsibilities 无菌生产