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Implement GMP compliance with global GMP standards and China GMP requirement
根據(jù)總部和中國GMP要求，執(zhí)行GMP符合性工作
● Ensure that QC specifications and analytical methods comply with applicable pharmacopeias requirements
確保QC的質(zhì)量標準和分析方法符合相關(guān)藥典要求
● Ensure that CMC regulatory submissions are aligned with QC specifications and analytical methods.
確保QC的質(zhì)量標準和分析方法和CMC注冊文件一致。
● Support Chinese Pharmacopeia commenting and implementation across the network
支持中國藥典在集團內(nèi)的意見反饋與執(zhí)行
● Maintenance of Master Method Validation Plan and the timely execution of method validation protocols and reports
維護驗證主計劃，及時執(zhí)行方法驗證計劃和報告。
● Excute analytical transfers and local analytical method verifications.
執(zhí)行分析方法轉(zhuǎn)移和本地分析方法確認。
● Provide technical guidance on test methods and relevant procedures.
對測試方法和檢測過程提供技術(shù)支持。
● Provide QC technical support and oversight to CMO activities
對CMO活動提供QC技術(shù)支持和監(jiān)督
● Support regulatory inspections and partner audits
支持官方審計和合作伙伴審計
● Sample receipt, storage, distribution and disposal procedure management.
樣品的接收、存儲、分發(fā)及處理流程的管理。
● Reference and retention sample management.
參考留樣及常規(guī)留樣的管理。
● Packaging material standard sample management.
包材的標準樣管理。
● Reference standards management
標準品管理
● Third party QC labs management
第三方實驗室管理。
● Ensure support on manufacturing operations through troubleshooting and other product lifecycle testing.
確保支持生產(chǎn)過程中的故障排除和其他的產(chǎn)品生命周期測試。
● Manage the trending process in labs according to Roche PQS requirements and regulations
根據(jù)羅氏PQS和法規(guī)要求，管理實驗室的趨勢分析流程
● Stability program - chamber management, coordination with global and laboratories for timely execution of stability protocols and stability report, stability trending
穩(wěn)定性安排-箱子管理、協(xié)調(diào)總部和實驗室以保證穩(wěn)定性方案、報告以及穩(wěn)定性趨勢分析的及時執(zhí)行
● QC metrics generation and report, managing performance of quality system processes (TCM, Discrepancies, CAPA, etc) for QC
QC量度的生成及報告，管理QC相關(guān)的質(zhì)量體系（變更、偏差、CAPA等）的指標
Qualifications and Experience
● Bachelor's Degree and above (Pharmacy, Master's Degree is preferred)
本科及以上學歷（藥學，碩士以上學歷優(yōu)先考慮）
● More than 3 years pharmaceutical or related company
三年以上醫(yī)藥及相關(guān)領(lǐng)域工作經(jīng)驗
● Excellent verbal and written English skill
出色的英語口語及書面能力
● Excellent project leading experience
出色的項目管理經(jīng)驗