職位描述
職位描述:
Responsibilities:
· Review automation system qualification and validation documents
審核自動(dòng)化系統(tǒng)確認(rèn)和驗(yàn)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(duì)確認(rèn)和驗(yàn)證的計(jì)劃和報(bào)告及相關(guān)文件的文件完整性、GMP符合性和數(shù)據(jù)可接受性進(jìn)行復(fù)核。
· Oversight of automation system qualification and validation activities’ execution
監(jiān)督自動(dòng)化系統(tǒng)確認(rèn)和驗(yàn)證活動(dòng)的實(shí)施
By governance the execution progress of qualification and validation activities to assure the compliance with company operating procedures, global guidelines, and regulatory.
監(jiān)督確認(rèn)和驗(yàn)證活動(dòng)的實(shí)施過(guò)程，確保符合公司操作規(guī)程、總部指南和法規(guī)要求。
· Oversight of calibration activities
監(jiān)督校準(zhǔn)活動(dòng)
By governance the progress of calibration activities to assure the compliance with company operating procedures, national standard, global guidelines, and regulatory.
監(jiān)督校準(zhǔn)活動(dòng)的實(shí)施，確保符合公司操作規(guī)程、國(guó)家標(biāo)準(zhǔn)、總部指南和法規(guī)要求。
· Validation documentation filling management
確認(rèn)和驗(yàn)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(jù)主管的要求支持其他質(zhì)量驗(yàn)證工作。
Requirements:
· Bachelor of Engineering Degree or above
工學(xué)士及以上學(xué)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(zhì)量、生產(chǎn)工作經(jīng)驗(yàn)，至少2年自動(dòng)化系統(tǒng)/設(shè)備方面經(jīng)驗(yàn)
· Professional knowledge of qualification, validation and pharma production
確認(rèn)、驗(yàn)證和制藥生產(chǎn)專業(yè)知識(shí)
· Knowledge of China/EU/FDA GMP requirements
中國(guó)/歐盟/FDA GMP知識(shí)
· Language skills – English & Chinese
語(yǔ)言能力-英語(yǔ)及中文
