崗位職責(zé)：
1.負(fù)責(zé)驗(yàn)證項(xiàng)目FL的團(tuán)隊(duì)建設(shè)，代表驗(yàn)證團(tuán)隊(duì)對(duì)接內(nèi)外部客戶，優(yōu)化項(xiàng)目管理流程和驗(yàn)證評(píng)估策略。
Responsible for team building of production project FL in validation team, to connect and communication with clients both internally and externally. Be responsible for optimizing project management process and validation evaluation strategies.
2.負(fù)責(zé)新建廠房的調(diào)試&驗(yàn)證工作。
Responsible for C&Q of new facilities.
3.負(fù)責(zé)CTU和運(yùn)輸驗(yàn)證工作。
Responsible for CTU qualification and shipping validation.
4.負(fù)責(zé)廠房設(shè)施和公用系統(tǒng)的驗(yàn)證工作
Responsible for the qualification of facilities and utilities.
5.負(fù)責(zé)對(duì)變更相關(guān)進(jìn)行驗(yàn)證技術(shù)評(píng)估。
Responsible for technical assessments of changes.
6.負(fù)責(zé)官方和客戶的審計(jì)，包括審計(jì)前的準(zhǔn)備工作和審計(jì)后的回復(fù)。
Responsible for official and client audits, including pre-audit preparation and post-audit responses.
7.完成領(lǐng)導(dǎo)安排的其他工作，定期向上級(jí)領(lǐng)導(dǎo)匯報(bào)工作進(jìn)展。
Complete other tasks assigned by the leader, and regularly reporting the progress to the superiors.

任職要求：
1.本科以上學(xué)歷，生物學(xué)和藥學(xué)相關(guān)學(xué)科。
Bachelor Degree above，major in biology or pharmacy.
2.8年以上制藥或者驗(yàn)證工作經(jīng)驗(yàn)。
At least 8 years of working experience in pharmaceutical or validation.
3.熟悉NMPA、FDA、EMA以及ISPE、PDA等法規(guī)指南對(duì)于驗(yàn)證的要求。
Be familiar with the requirements of validation according to the regulations and guides of NMPA, FDA, EMA, ISPE, and PDA etc.
4.相當(dāng)熟練的計(jì)算機(jī)使用技能。
Quite skillful in using computer software.
5.具備較豐富的項(xiàng)目管理經(jīng)驗(yàn)
Experienced in project management
6.較強(qiáng)的英語(yǔ)聽(tīng)說(shuō)讀寫(xiě)能力。
Fairly strong in spoken and written English language.