職位描述
職位描述:
Responsibilities:
· Review automation system qualification and validation documents
審核自動化系統確認和驗證文件
By compliance review of qualification and validation plans and reports, and other related documents for document completeness, GMP compliance and data acceptability.
對確認和驗證的計劃和報告及相關文件的文件完整性、GMP符合性和數據可接受性進行復核。
· Oversight of automation system qualification and validation activities’ execution
監督自動化系統確認和驗證活動的實施
By governance the execution progress of qualification and validation activities to assure the compliance with company operating procedures, global guidelines, and regulatory.
監督確認和驗證活動的實施過程，確保符合公司操作規程、總部指南和法規要求。
· Oversight of calibration activities
監督校準活動
By governance the progress of calibration activities to assure the compliance with company operating procedures, national standard, global guidelines, and regulatory.
監督校準活動的實施，確保符合公司操作規程、國家標準、總部指南和法規要求。
· Validation documentation filling management
確認和驗證文件歸檔的管理
· Support activities
支持工作
By providing support to other quality validation activities as required by superior.
根據主管的要求支持其他質量驗證工作。
Requirements:
· Bachelor of Engineering Degree or above
工學士及以上學位
· 4+ years39; experience in Quality Unit, Production in Pharma. Company. At least 2 years experience in automation system.
4年以上制藥公司質量、生產工作經驗，至少2年自動化系統/設備方面經驗
· Professional knowledge of qualification, validation and pharma production
確認、驗證和制藥生產專業知識
· Knowledge of China/EU/FDA GMP requirements
中國/歐盟/FDA GMP知識
· Language skills – English & Chinese
語言能力-英語及中文
