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Job Responsibilities/崗位職責(zé)

1.Participate in the construction and maintenance of the R&D system, participate in the management of the R&D system. Assist the implementation of the R&D quality system.

參與研發(fā)體系的建設(shè)及維護(hù)；參與研發(fā)系統(tǒng)的管理；協(xié)助研發(fā)質(zhì)量體系的實(shí)施；

2.Report any finding in R&D lab management to CTO weekly, and plan the improvement as needed.

每周向CTO匯報(bào)研發(fā)實(shí)驗(yàn)室管理工作中發(fā)現(xiàn)的問(wèn)題，并提出整改措施；

3.Responsible for the management of the daily activities of R&D site, supervise the R&D site and its improvement, including on-site records, equipment management, daily maintenance, personnel operation, etc.

負(fù)責(zé)日常研制現(xiàn)場(chǎng)日常活動(dòng)的管理，對(duì)研發(fā)現(xiàn)場(chǎng)進(jìn)行督察并監(jiān)督整改，包括現(xiàn)場(chǎng)記錄、設(shè)備管理、日常維護(hù)、人員操作等；

4.Responsible for the distribution and review of R&D original records. Responsible for R&D experimental notebook standardization, Audit the completeness, authenticity of all the data, and write the audit records and reports. Review the timeliness, authenticity, completeness of auxiliary records.

負(fù)責(zé)研發(fā)原始記錄的分發(fā)和審核管理；研發(fā)實(shí)驗(yàn)記錄本規(guī)范性、完整性、數(shù)據(jù)真實(shí)性抽查，并形成記錄和報(bào)告；輔助記錄及時(shí)性、真實(shí)性、完整性抽查；

5.Responsible for the review process instruction, batch production records, quality standards, verification plans/reports, testing procedures, testing records/reports and other documents for R&D.

負(fù)責(zé)研發(fā)用工藝規(guī)程草案、部分批生產(chǎn)記錄、質(zhì)量標(biāo)準(zhǔn)、確認(rèn)方案/報(bào)告、檢驗(yàn)操作規(guī)程、檢驗(yàn)記錄/報(bào)告等文件的審核；

6.Responsible for R&D material management, including purchasing, requisitioning, inventory,etc.

負(fù)責(zé)研發(fā)物料管理，包括采購(gòu)、領(lǐng)用、庫(kù)存盤(pán)點(diǎn)等；

7.Training of R&D staff related to laboratory management.

對(duì)研發(fā)人員進(jìn)行實(shí)驗(yàn)室管理相關(guān)的培訓(xùn)工作；

8.Complete other tasks arranged by superiors.

完成上級(jí)安排的其他工作。

Job Requirements/崗位要求

1.Bachelor degree, science subject is preferred.

本科學(xué)歷，科學(xué)學(xué)科優(yōu)先考慮；

2.1-5 years of lab management industry experience, pharmaceutical or medical device experience is preferred. Those with quality management experience in biopharmaceutical are better.

1-5年實(shí)驗(yàn)室管理行業(yè)經(jīng)驗(yàn)，制藥或醫(yī)療器械經(jīng)驗(yàn)優(yōu)先考慮。具備生物制藥質(zhì)量管理經(jīng)驗(yàn)者更好；

3.Self-motivated, capable of handling independently, organizing and arranging multiple tasks, and able to perform under pressure and in line with the timeline.

有上進(jìn)心，有能力獨(dú)立處理，組織和善于安排多項(xiàng)任務(wù)，并能在壓力下執(zhí)行并符合時(shí)間線；

4.In-depth knowledge of GXPS and related guidelines and regulatory requirements.

熟悉GXPS和相關(guān)指南、法規(guī)要求；

5.Good oral and written communication skills in English and Mandarin, able to communicate effectively with other functional departments.

良好的英語(yǔ)和普通話口語(yǔ)和書(shū)寫(xiě)交流能力，能有效與其他職能部門(mén)溝通。