Applicable Laws Jobs in China

责任描述和工作范围运营管理按计划完成生产所需要的管路器具组装灭菌溶液配置等生产任务管理外包员工配合生产完成样品递送等工作生产部门清洁消毒人员行为更衣的管理工作起草更新相关SOP文件及时对发现的问题进行跟踪处理生产外包清洗服务公司的对接和管理工作生产部门废弃物的灭活和处置生产内部非GMP物料的统计和采购申请...

Major responsibilities Facility & Utilities Qualification (URS/DQ/IQ/OQ/PQ): Coordinate qualification of cleanrooms (ISO classes) HVAC process gases and PW/PS systems; ensure environmental monitoring programs are defined and validated.Equipment Qualification: Plan and witness the IQ/OQ/PQ for critic...

责任描述和工作范围运营管理按计划完成生产所需要的管路器具组装灭菌溶液配置等生产任务配合生产完成样品递送补料申请等操作负责部门内清洁外包服务人员的管理包括人员招聘培训KPI考核和工作安排等负责生产部门清洁消毒人员行为更衣的管理工作起草更新相关SOP文件及时对发现的问题进行跟踪处理负责生产外包清洗服务公司的对...

Major responsibilities On shop floor quality oversight for cell therapy products to ensure product batch is manufactured according to approved procedure and in compliance with current GMP requirementsPerforms the QA review and approval of the following GMP documentation as it relates to the oversigh...

责任描述和工作范围运营管理负责部门内偏差调查和变更控制工作以及偏差CAPA有效性的分析与回顾推动持续改进负责部门风险评估活动法规差距分析推动合规体系建设持续识别生产过程中的GMP符合性与操作风险进行工艺流程和数据分析推动生产流程优化与标准化持续提升生产效率与质量起草定期回顾优化生产部门工艺和管理类文件支持...

Major responsibilitiesPerform microbiological testing-related work including pharmaceutical microbial limits testing sterility testing bacterial endotoxin testing cleaning validation cleanroom environmental monitoring and strain bank/library testing.Participate in developing microbiological quality...

SUMMARY OF THE ROLEAs part of AstraZenecas Cell Therapy Discovery the R&D department is primarily responsible for the early-stage development of cell therapy products The role holder will participate in early-stage project research and the design of technical strategies independently lead validation...

Major responsibilities Receive regular GMP training regulatory training and company role training/assessments; attend data reliability training on schedule to strengthen awareness of data reliability.Comply with company and role-related requirements; participate in establishing GMP-compliant physico...

Major responsibilities Performs QC laboratory shop floor quality oversight to ensure product testing is conducted in accordance with approved procedures and in compliance with current GMP requirementsPerforms the QA review and approval of the following GMP documentation as it relates to the oversigh...

Typical Accountabilities The role; is seen as a AZSS examplar and possesses the ability to continually delevop their capabilities inline with current and evolving best practicewill provides coaching facilitation and expertise in topics including but not limited too AZSS TPM Digital Transformation si...

Support commissioning and validation of new factory automation systems takeover and manage the BMS and EMS systems; Takeover and manage the operations and maintenance of other automation systems (such as high-efficiency plant rooms chiller and air compressor cluster control systems); Technical up...

SUMMARY OF THE ROLEYou will be accountable for program/project management activities within the Pharmacology and Toxicology (PT) team as part of the broader Cell Therapy Discovery organization with primary focus on CAR-T programs. You will translate scientific strategy into integrated executable pla...

Typical AccountabilitiesThe role; is seen as a AZSS examplar and possesses the ability to continually delevop their capabilities inline with current and evolving best practicewill provides coaching facilitation and expertise in topics including but not limited too AZSS TPM Digital Transformation six...

Typical AccountabilitiesThe role will support APAC lean Academy:On-Time On-Quality Delivery: Accountable for meeting training program timelines scope and quality standards across the full lifecycle.Data Integrity and Governance: Accountable for accuracy of data in Forms SharePoint lists OneNote and...

SUMMARY OF THE ROLEYou will lead in vivo study strategy study leadership and vendor/CRO governanceto enable data-driven progression of programs from discovery toward translation with priority focus on (1) cell therapy followed by (2) immuno-oncologyand (3) immunology. This role is primarily accounta...

Equipment maintenance within Packing PET and complete relevant documentation work in compliance with GMPrequirement.按照GMP 的要求维护包装生产流程执行团队相关生产设备的日常维护活动并负责完成相关文件工作Production equipmentmaintenance生产设备维护 Carry out routine preventive maintenance plan together...

Typical Accountabilities (per AZ framework and regulatory expectations):Acting as the quality Approval / Decision maker for the GxP relevant procedure in Astrazeneca Distribution Facility. Ensure the compliance with internal Astrazeneca requirement and also relevant market Healthy Authority Requirem...

协助助理总监制定公用介质部门管理策略及规则管理并实施公用介质系统的机械电气自动系统维修维护工作故障解决根据生产情况制定合理的介质供应维护计划提高能源运行效率降低能耗水平并稳定地提供产品相关的业务员工和访客需要的动力介质供应以营造一个良好的工作环境支持或驱动业务发展 Typical Accountabilities 主要职责 U...

Brief Job DescriptionAssist utility associate director in developing management policies and rules for the utility team. Responsible maintenance work of mechanical electrical and automation utility system trouble shooting in compliance and stably supply all qualified utility media service for all me...

Brief Job Description 工作描述简述Finish routine analytical work for products accurately. Maintain the instruments in good status and develop professional skills. Finish routine management of reference standards / reagents / consumables to support lab tests performed smoothly.Manage specification an...