招聘人数:1-2人
到岗时间:不限
年龄要求:不限
婚况要求:婚姻状况
Responsible for SVMP establishment and implementation, including equipment validation, facility validation, process validation and software validation if any;
负责工厂验证主计划的制定和执行,包括设备确认、厂房确认、过程验证和软件验证;
Responsible for site wide validation training;
负责工厂范围的验证培训;
Review process FMEA as necessary;
必要时审核过程FMEA;
Establish and maintain calibration program with compliance to related regulation and equipment/instrument user requirement;
负责执行和维护校验规程,确保符合相关法规要求和设备/仪器要求;
Be engaged with design control process to develop process validation strategy;
参与设计控制过程,制定过程验证策略;
Responsible for Validation resources management, including human resources, equipments/instruments, facilities, etc, to ensure timely validation task implementation, as well as supportive task to other group or department if required;
负责验证资源管理,包括人力资源、设备仪器、厂房等,确保及时管理验证风险,以及支持其他团队或部门,如需;
Review and approve validation deviation/discrepancy as required.
审核批准验证偏差;
Support change management at site.
支持工厂变更管理;
Support Quality Assurance routine activities.
支持质量保证日常活动。
Bachelor degree or above
本科或以上学历
Bio-science or medicine related is a plus
生命科学或医药相关学历优先
2 years Validation Experience medical device, pharmaceutical, or food related industry.
具有2年医疗器械、制药或相关食品行业验证工作经验
Effective communication skills
有效沟通交流技能
Project Management skills
项目管理技能
Knowledge of Lean and Six Sigma for Manufacturing
精益生产和六西格玛知识
Training and education skills
培训技能
Knowledge of analytical and statistical tools
分析和统计工具知识
Knowledge of site processes
工厂过程知识
Set priorities among multiple tasks
多重任务优先管理
Demonstrate effective leadership
执行有效管理
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