该职位来源于猎聘 此职位为项目合同,公司合同工资面议 职责描述: Develop and execute computer system validation plans and strategies 制定并执行计算机系统验证计划和策略 Conduct risk assessments to determine validation scope and depth 风险评估以确定验证范围的范围和深度 Create validation protocols (IQ/OQ/PQ) and validation reports 编写要验证方案(IQ/OQ/PQ)和验证方案 Manage validation project timelines and resource allocation 管理项目的验证时间和资源分配 Create and maintain validation documentation packages 创建和维护验证文件 Perform system testing and test script execution 执行系统测试及测试脚本运行 Investigate system deviations and implement corrective actions 发现系统偏差并实施纠错措施 Initiate and manage change control processes for validated systems 发起并管理验证系统的变更流程 Ensure systems comply with FDA 21 CFR Part 11, EU GMP Annex 11, ICH Q7, and other relevant regulations 确保系统符合FDA 21 CFR Part 11, EU GMP Annex 11, ICH Q7及其他相关法规要求 Establish and maintain CSV-related SOPs and work instructions 建立并维护计算机系统验证相关标准操作规程和工作说明 职位要求: Bachelor's degree in Pharmaceutical Sciences, Computer Science, Engineering, or related field,5-7 years of experience in pharmaceutical/biotech industry 大学本科毕业,药学、计算机科学、工程或相关领域学士学位,5-7年制药/生物技术行业工作经验 Strong understanding of GxP regulations and quality systems 熟悉GXP法规和质量验证系统 English fluency is a must 英语流利 Sound Knowledge of data integrity principles 熟悉数据完整性原则。 Understanding & experience of network infrastructure qualification is strongly sought. 具有网络基础设施认证的理解和经验 Expertise in qualification of QC computer sytems 具有质量控制计算机系统认证的专业知识 Expertise in qualification of manufacturing control systems 具有制造控制系统认证的专业知识 Project management skills around task management with ability to handle multiple concurrent tasks and report progress in daily standups for your discipline. 具有项目管理能力并能同时处理多项同步任务,及时汇报项目进展 Excellent written and verbal communication skills 出色的书面与口头沟通能力 Continuous learning mindset to stay current with evolving regulations 持续学习新的法规