职位描述
职位描述:
Responsibilities:
· Review automation system qualification and validation documents
审核自动化系统确认和验证文件
By compliance review of qualification and validation plans and reports, and other related documents for document completeness, GMP compliance and data acceptability.
对确认和验证的计划和报告及相关文件的文件完整性、GMP符合性和数据可接受性进行复核。
· Oversight of automation system qualification and validation activities’ execution
监督自动化系统确认和验证活动的实施
By governance the execution progress of qualification and validation activities to assure the compliance with company operating procedures, global guidelines, and regulatory.
监督确认和验证活动的实施过程，确保符合公司操作规程、总部指南和法规要求。
· Oversight of calibration activities
监督校准活动
By governance the progress of calibration activities to assure the compliance with company operating procedures, national standard, global guidelines, and regulatory.
监督校准活动的实施，确保符合公司操作规程、国家标准、总部指南和法规要求。
· Validation documentation filling management
确认和验证文件归档的管理
· Support activities
支持工作
By providing support to other quality validation activities as required by superior.
根据主管的要求支持其他质量验证工作。
Requirements:
· Bachelor of Engineering Degree or above
工学士及以上学位
· 4+ years39; experience in Quality Unit, Production in Pharma. Company. At least 2 years experience in automation system.
4年以上制药公司质量、生产工作经验，至少2年自动化系统/设备方面经验
· Professional knowledge of qualification, validation and pharma production
确认、验证和制药生产专业知识
· Knowledge of China/EU/FDA GMP requirements
中国/欧盟/FDA GMP知识
· Language skills – English & Chinese
语言能力-英语及中文
