-Coordinate?testing?plan?of?the?raw?materials,?semi-finished,?finished?products,?validation?sample?and?project?sample?according?to?plan,?assure?the?test?were?carried?out?on?time?according?to?the?analytical?methods?and?pharmacopoeia?requirements.
按照計劃組織協(xié)調(diào)實驗室原輔料，半成品，成品，驗證樣品和項目樣品的檢驗，確保檢驗工作按照分析方法和藥典要求進(jìn)行并按時完成。
-Assist?to?promote?project?analysis?technology?research,?undertake?project?analytical?method?development?and?method?validation,?develop?appropriate?and?effective?analysis?method.
協(xié)助推進(jìn)項目分析技術(shù)研究，承擔(dān)項目的分析方法開發(fā)和方法驗證，開發(fā)合適有效地分析方法。
-Support?the?QC?manager?to?carry?out?the?investigation?of?OOS?and?assure?the?appropriate?CAPA?was?made?and?implemented.
支持QC經(jīng)理進(jìn)行實驗室檢驗異常情況的調(diào)查并確保制定合適的預(yù)防整改措施并實施。
-Assure?the?analytical?instruments?in?QC?were?maintained,?validated/verified?and?calibrated?on?time.?
確保QC?實驗室儀器按時進(jìn)行維護(hù)、驗證/確認(rèn)、并經(jīng)過校驗。-Maintain?the?reference?standards?as?well?as?the?relevant?documentation?and?record.?Maintain?the?reagents?and?their?records.
維護(hù)對照品的管理及記錄。維護(hù)試劑的管理及記錄。
-Draft?procedures,?qualification?protocols?of?the?analytical?instruments?and?the?analytical?methods?validation?plans.?-?Complete?the?analysis?RD?reports?on?time?as?required.
編寫標(biāo)準(zhǔn)操作規(guī)程、儀器確認(rèn)草案及分析方法驗證方案,按時按要求完成分析方法報告。
-Implement?stability?study?according?SOP?and?finish?stability?report?on?time
根據(jù)SOP完成穩(wěn)定性研究，并及時完成穩(wěn)定性報告。
-?Some?experience?needed?in?industry?and?wide?knowledge?of?industrial?methods?of?analysis?(GC,HPLC,MS?,wet?chemistry?but?also?good?knowledge?in?NMR?;IRFT,?UV?and?other?quantitative?analytical?methods?like?AA?,ICP-AES??…for?anion;cations?analysis?for?exemple?)
-Familiar?with?cGMP?quality?management?and?principle?and?pharmaceutical?industry?.