-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)助推進項目分析技術研究，承擔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)理進行實驗室檢驗異常情況的調查并確保制定合適的預防整改措施并實施。
-Assure?the?analytical?instruments?in?QC?were?maintained,?validated/verified?and?calibrated?on?time.?
確保QC?實驗室儀器按時進行維護、驗證/確認、并經(jīng)過校驗。-Maintain?the?reference?standards?as?well?as?the?relevant?documentation?and?record.?Maintain?the?reagents?and?their?records.
維護對照品的管理及記錄。維護試劑的管理及記錄。
-Draft?procedures,?qualification?protocols?of?the?analytical?instruments?and?the?analytical?methods?validation?plans.?-?Complete?the?analysis?RD?reports?on?time?as?required.
編寫標準操作規(guī)程、儀器確認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?.