崗位職責：
1.?Ensure?that?all?Validation?personnel?are?appropriately?trained?for?their?positions.確保所有的驗證人員已接受崗位培訓。
2.?Prepare,?review,?implement?and?maintain?Validation?SOPs.
起草、審核、實施和維護驗證SOP。
3.?As?required?participate?in?the?Weekly?Quality?Organization?Meeting.
根據(jù)需要參加每周質(zhì)量部會議。
4.?As?required?participate?in?the?Monthly?Quality?Organization?and?Operations?Organization?Meeting.
根據(jù)需要參加月度質(zhì)量部和運營部會議。
5.?As?required?participate?in?the?Quarterly?Management?Review?Meeting.
根據(jù)需要參加季度管理審核會議。
6.?Update?and?maintain?the?Validation?Master?Plan.
更新和維護驗證主計劃。
7.?In?conjunction?with?Operations?and?in?accordance?with?the?Validation?Master?Plan?prepare?GAMP?documentation?for?new?equipment?and?systems.
與運營部協(xié)同按照驗證主計劃為新設(shè)備和系統(tǒng)制定GAMP文件。
8.?In?conjunction?with?Operations?review?supplier?submitted?documentation?for?new?equipment?and?systems.
與運營部協(xié)同審核供應(yīng)商提交的新設(shè)備和系統(tǒng)的文件。
9.?In?conjunction?with?Operations?and?in?accordance?with?the?Validation?Master?Plan?prepare?qualification?and?validation?protocols?for?new?equipment?and?systems.
與運營部協(xié)同按照驗證主計劃起草新設(shè)備和系統(tǒng)的確認和驗證方案。
10.?In?conjunction?with?Operations?execute?qualification?and?validation?protocols?for?new?equipment?and?systems.
與運營部共同執(zhí)行新設(shè)備和系統(tǒng)的確認和驗證方案。
11.?In?conjunction?with?Operations?document?/?resolve?deviations?identified?when?executing?qualification?and?validation?protocols?for?new?equipment?and?systems.
與運營部共同記錄/解決新設(shè)備和系統(tǒng)確認和驗證方案執(zhí)行中發(fā)現(xiàn)的偏差。
12.?Prepare?qualification?summary?reports?for?executed?qualification?and?validation?protocols?for?new?equipment?and?systems.
為已執(zhí)行確認和驗證的新設(shè)備和系統(tǒng)起草確認總結(jié)報告。
13.?In?conjunction?with?Operations?and?in?accordance?with?the?Validation?Master?Plan?prepare?revalidation?protocols?for?validated?equipment?and?systems.
與運營部共同按照驗證主計劃為已驗證的設(shè)備和系統(tǒng)起草再驗證方案。
14.?In?conjunction?with?Operations?execute?revalidation?protocols?for?validated?equipment?and?systems.
與運營部共同執(zhí)行設(shè)備和系統(tǒng)的再驗證方案。
15.?In?conjunction?with?Operations?document?/?resolve?deviations?identified?when?executing?revalidation?protocols?for?validated?equipment?and?systems.
與運營部共同記錄/解決在執(zhí)行設(shè)備和系統(tǒng)的再驗證方案過程中出現(xiàn)的偏差。
16.?Prepare?qualification?summary?reports?for?executed?revalidation?protocols?for?validated?equipment?and?systems.
起草已執(zhí)行再驗證方案的設(shè)備和系統(tǒng)的確認總結(jié)報告。
17.?Verify?that?all?test?equipment?is?in?the?appropriate?calibrated?state?before?use.
確認所有的檢驗設(shè)備在使用前已經(jīng)過適當?shù)男省?br />18.?Ensure?that?all?test?equipment?is?in?the?appropriate?calibrated?state?before?use.
確保所有的檢驗設(shè)備在使用前已經(jīng)過適當?shù)男省?br />19.?Notify?the?Manager?of?the?QA?Department?immediately?if?a?requirement?of?any?qualification,?validation?or?revalidation?protocol?fails?to?be?met.
如果在確認、驗證或再驗證方案的執(zhí)行過程中出現(xiàn)不符合情況，及時通知QA經(jīng)理。
20.?In?conjunction?with?Operations?maintain?equipment?and?systems?documents?(including?GAMP?documents).
與運營部協(xié)同維護設(shè)備和系統(tǒng)文件（包括GAMP文件）。
21.?Maintain?the?equipment?and?systems?qualification,?validation?and?revalidation?documents.
保存設(shè)備和系統(tǒng)的確認、驗證和再驗證文件。
22.?Maintain?the?equipment?and?systems?qualification?and?validation?document?log.
維護設(shè)備和系統(tǒng)的確認和驗證文件臺賬。
23.?Complete?any?other?work?task?assigned?by?engineer?manager.
完成工程部經(jīng)理分配的其他工作任務(wù)。?
任職要求：
1.Excellent?organizational,?communication,?and?interpersonal?skills.
良好的組織、溝通和人際交往能力。
2.Strong?analytical?and?leadership?skills.
強大的分析和領(lǐng)導(dǎo)能力。
3.Problem?analysis?and?problem?solving?experience.
問題分析和問題解決經(jīng)驗。
4.Planning?and?organizing.
計劃和組織能力。
5.Good?Judgment?and?decision?making.
良好的判斷和決策能力。
6.Ability?to?work?independently.
能夠獨立完成工作。
7.Outstanding?organizational?skills.
出色的組織能力。
8.Ability?to?operate?in?a?fast-paced,?multi-disciplinary?industrial?environment.
能夠操作一個快節(jié)奏的、多學科的工業(yè)環(huán)境。
9.Understanding?and?proficiency?on?managing?software?programs?such?as?Words,?PowerPoint,?and?Excel.
了解并熟練使用管理軟件如Words,?PowerPoint,?and?Excel。
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