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崗位職責：
Job responsibility
1.負責批準質(zhì)量標準，分析方法及CoA。Responsible for approving the issued specification, analysis method and CoA.
2.負責實驗室標準操作規(guī)程的審核，批準。Responsible for reviewing and approving the standard operation procedure.
3.負責分析實驗室 OOS，異常事件，偏差及變更的審核，批準。Responsible for review and approving the OOS, OR, deviation and change control in analytical laboratory.
4.負責分析實驗室檢測數(shù)據(jù)審核批準，分析儀器驗證報告的審核批準。Responsible for review and approval of analytical laboratory test data and analytical instruments qualification reports.
5.負責確保分析實驗室的日常監(jiān)督檢查有效執(zhí)行，批準巡檢報告.Responsible for ensuring the effective implementation of routine inspection in the analytical laboratory and approve the routine inspection reports.
6.負責合同實驗室的管理及審計。Responsible for contract laboratory management and audit.
7.起草分析實驗室管理相關(guān)的質(zhì)量管理文件。Draft quality management documents related to the management of analytical laboratories.
8.參與客戶審計及相關(guān)準備工作。Participate in customer audits and related preparation work.
9.完成領(lǐng)導(dǎo)安排的其他工作。Complete the work assigned by leaders.
任職資格：
1.本科或以上學(xué)歷，化學(xué)、藥學(xué)、制藥工程等相關(guān)專業(yè)。Bachlor or above degree in chemistry or pharmaceutical or related majors.
2.五年以上制藥或CRO行業(yè)QA+QC工作經(jīng)驗。有團隊管理工作經(jīng)驗優(yōu)先考慮.At least 5 years of QA+QC working experience in the pharmaceutical or CRO industry, with team management experience is preferred.
3.具有一定的化學(xué)基礎(chǔ)知識。Have certain chemistry basic knowledge.
4.熟悉ICH Q7, GMP等相關(guān)法規(guī)。Familiar with ICH Q7, GMP and relevant regulations.
5.有很強的工作條理性、計劃性及任務(wù)執(zhí)行能力。Have a strong work logic，planning ability and strong ability of task execution.
6.具有很強的跨廠區(qū)、跨部門溝通能力，團隊協(xié)作意識和溝通技巧。Have strong ability of cross-site & cross-department communication, sense of teamwork and communication skills. .
7.英語口語流利。Fluent in oral English.