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工作內(nèi)容：
1.分析文件審核 。Analytical document review.
(1)審核并批準質(zhì)量標準、分析方法、方法驗證及報告、分析報告（CoA）等相關(guān)文件。
Review and approval of Specification, analysis method, method validation reporting, Certificate of analysis (CoA), and other relevant documents.
(2)審核和批準GMP生產(chǎn)設(shè)備清潔分析方法，驗證方案及報告。
Review and approve the cleaning method, protocol and report of equipment that are used for GMP manufacture.
(3)車間生產(chǎn)中控分析、批檢驗記錄的審核和批準。
Review and approve In-Process of analytical data sheet.
(4)審核并批準分析儀器的確認 校準方案、報告及儀器標簽的發(fā)放。
Review and approval of the protocol report for analysis instrument qualification calibration. And distribution of the instrument tag.
(5)審核并批準分析儀器計算機化系統(tǒng)的驗證的方案、報告。
Review and approve the validation protocol and report of computerized system for analysis instrument.
(6)審核并批準穩(wěn)定性方案及報告，每周及每月對穩(wěn)定性試驗箱的溫濕度數(shù)據(jù)進行審核
Review and approve stability study protocol report, weekly and monthly review temperature humidity data of the stability test chamber.
(7)定期對純化水報告進行審核。
Periodically review the purified water reports
(8)參與分析相關(guān)的偏差，變更，OOS的調(diào)查。
Participate in the deviation, change controls and OOS investigations about analysis.
(9)確認分析異常事件，并發(fā)放分析異常事件調(diào)查編號并審批異常事件調(diào)查報告。
Confirm the lab occurrence event, and issue OR number of lab event, review and approve OR report of analytical department.
(10)批準客戶要求的或特殊要求的Non-GMP相關(guān)的分析文件。
Approve analytical document related to Non-GMP according to client requirement or special requirement.
(11)批準并歸檔特殊物料申請單，并通知相關(guān)人員。
Approve and archive special materials application forms, and notify relevant personnel timely
(12)分析部門監(jiān)督。
Inspection of analytical department.
(13)審核并發(fā)放相關(guān)部門申請的物料、中間體和終產(chǎn)品的質(zhì)量標準號。
Review and issue the Specification Number for materials, intermediates and final products that are applied by related department.
(14)協(xié)助分析文件管理員完成部分文件管理工作。
Assist the analysis document administrator to complete some document management work.
(15)合同實驗室的管理和維護。
Maintain and manage of contract laboratory.
(16)定期對GMP分析實驗室進行抽查，包括實驗室規(guī)范、記錄、儀器使用記錄和維護、人員操作等。
Periodically check GMP analysis laboratory, including laboratory specification, record, instrument use and maintenance, operation, etc.
(17)參加公司組織的自檢，對與分析部門發(fā)現(xiàn)的缺陷進行跟蹤。
Participate the Internalaudit, follow up the audit finding related with analytical department.
2.其他工作 Other Tasks
(1)起草、審核、修訂本職責相關(guān)的文件；
Draft, review and revise the QA duties files.
(2)審核分析部門相關(guān)GMP SOP；
Review GMP SOP for analytical department.
(3)執(zhí)行本部門領(lǐng)導臨時安排的工作。
Perform any temporary assigned task.
教育背景及任職資格：
1. 教育背景：化學、分析化學、藥學或其他相關(guān)專業(yè)本科及以上學歷。
Education Background: Bachelor degree or above in Chemistry, Analytical Chemistry, Pharmacy or related majors.
2. 經(jīng)驗：具有至少2年從事在醫(yī)藥行業(yè)藥品檢驗實踐經(jīng)驗，接受過與其職責相應(yīng)的GMP培訓。
Experience: At least 2 years experience in the field of drug product analysis in pharmaceutical industry. Received GMP training appropriate to the duties assigned to them.
3. 技能技巧：具有一定的英語能力，應(yīng)能閱讀USP/EP/ICH等藥品分析相關(guān)的專業(yè)資料。
Skills: Appropriate English skills are required. Capable to read analytical professional documents, such as USP/EP/ICH etc.