-functional teams to implement GMP-related systems, processes, and workflows for the production department. ● Develop... and implement GMP training programs tailored to production staff, aligned with corporate quality policies and regulatory...
Job Description: Position Scientific Experienced Engineer – External Supply Integration (ESI) Temporary role based in Shanghai, China... an External Supply Integration (ESI) Scientific Experienced Engineer to act as the PSES lead for clinical drug product...
. ● Perform other duties as assigned. Routine Operation: ● Ensure routine operation in compliance with Roche’s GMP/SHE... validation activities, such as APS. ● Ensure data accuracy, integrity, and traceability for the activities in the GMP area...
Operation: Ensure routine operation in compliance with Roche’s GMP/SHE and regulation requirements. Performing the following... activities in the GMP area. Related IT system operations, such as SAP, MES, Veeva, Cornerstone. Perform other duties...
compliance with industry standards, customer requirements, and regulatory norms (such as ISO 13485, China GMP). The ideal...要求及法规规范（如 ISO 13485、中国 GMP）。理想候选人需在后段工序（喷砂、酸蚀、阳极氧化、激光打标、改性处理等）具备深厚专业知识，精通过程质量控制，拥有出色的数据分析与工艺优化能力。 This position is based...
排查并解决自动化系统故障，提供技术支持，确保生产连续性。 61 根据GMP要求，编制和维护相关自动化系统的操作规程和验证文件。 61 与跨部门团队合作，推动自动化改进项目，提高生产效率和质量。 61 参与设备升级及新项目的自动化方案评估和实施。 61 协助... and maintain SOPs and validation documents for automation systems in compliance with GMP requirements. 61 Collaborate with cross...
qualification team as required (such as Time-based Requalification). Periodic Review Execution: Execute periodic review of GMP..., give guidance to the other engineer in the team. Coordinate Qualification Implementation within technical division...
inspection. Ensure that all manufacturing activities strictly adhere to national and international GMP regulations while actively...（Deviation）与纠正预防措施（CAPA）的全生命周期管理、批记录收集以及留样检查。确保生产活动严格符合国家及国际 GMP 法规要求，并积极维护工厂的 EHS（环境、健康、安全）标准。 GE HealthCare is a leading...
(safety, environment, GMP, food safety, KORE). - Conducts regular project reviews evaluating progress, risks, budget... plans to close engineer skill gaps crucial for digital transformation. - Champions continuous learning, technology...
installation, commissioning, IQOQ, Validation, GMP Knowledge; Having Field Service Engineer experience will be more advantageous...