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職位職責：
1.依據(jù)公司內(nèi)部SOP，以及相關(guān)法規(guī)、指南或行業(yè)標準，見證供應商的驗證/確認的執(zhí)行。Witness the implementation of supplier verification/validation in accordance with the company's internal SOP and relevant regulations, guidelines or industry standards.
2.負責起草驗證/確認方案和報告，包括空調(diào)系統(tǒng)、軟化水系統(tǒng)、熱水系統(tǒng)、純化水系統(tǒng)、注射用水系統(tǒng)、壓縮空氣系統(tǒng)、氮氣系統(tǒng)、生產(chǎn)設備、庫房溫濕度分布。Responsible for drafting validation/qualification protocol and reports, Including air conditioning system, softened water system, hot water system, purified water system, water for injection system, compressed air system, nitrogen system, production equipment, warehouse temperature and humidity distribution.
3.負責審核所有驗證的相關(guān)數(shù)據(jù)，并進行趨勢分析。Responsible for reviewing all relevant validation/qualification data and trend analysis.
4.識別驗證/確認測試中的偏差，并提供解決偏差的建議。Identify deviations from validation/qualification tests and provide recommendations for resolving deviations.
5.負責驗證/確認所用測試儀器/設備的SOP的編寫和執(zhí)行。Responsible for the preparation and implementation of Sops for validation/qualification of the test instruments/equipment used.
6.負責驗證/確認所用測試儀器/設備的維護保養(yǎng)工作。Responsible for validation/qualification the maintenance of the test instruments/equipment used.
7.完成其他相關(guān)工作。Execute other related tasks.
職位要求：
1.藥學、制藥工程等相關(guān)專業(yè)本科及以上。Bachelor degree or above in pharmacy, pharmaceutical engineering and other related majors.
2.三年以上制藥或相關(guān)行業(yè)驗證工作經(jīng)驗。More than 3 years’ experience in validation in pharmaceutical or related industries.
3.有口服固體制劑或無菌制劑醫(yī)藥行業(yè)驗證工作經(jīng)驗為佳。Experience in the validation of oral solid or sterile preparations in the pharmaceutical industry.
4.應熟悉空調(diào)系統(tǒng)、純化水系統(tǒng)、注射用水系統(tǒng)、壓縮空氣系統(tǒng)、氮氣系統(tǒng)、生產(chǎn)設備、計算機化系統(tǒng)等其中的2種以上的系統(tǒng)。Be familiar with more than two systems of air conditioning system, purified water system, water for injection system, compressed air system, nitrogen system, production equipment, computerized system, etc.
5.具備對問題的分析、判斷及解決能力。Have ability of problem analysis, judgment and resolution.
6.具備良好的溝通交流能力。Have good communication ability.
7.熟練使用Office、CAD等辦公軟件。Skilled in Office, CAD, and other office software.
8.具備基本英語知識。Have basic English knowledge.