1. To be responsible for tech transfer on behalf of MFG USP/DSP.
代表上游/下游生產(chǎn)負(fù)責(zé)技術(shù)轉(zhuǎn)移；
2. Participate in the evaluation of new technology, new production
process and new production technology.
參與評(píng)估新工藝、新生產(chǎn)流程和新生產(chǎn)技術(shù)；
3. Make project BOM per required; Draft MPI and BPR per the process.
根據(jù)要求起草項(xiàng)目BOM；根據(jù)工藝要求寫工藝規(guī)程和批記錄；
4. As the representative of the production department, handle material qualification and supplier qualification.
作為生產(chǎn)部的代表處理物料確認(rèn)和供應(yīng)商確認(rèn)；
5. As a representative of the production department, respond to quality audits from the administrative supervision departments and customers.
作為生產(chǎn)部代表應(yīng)對(duì)來自行政監(jiān)管部門和客戶的質(zhì)量審計(jì)；
Participate in the internal auditing program for company as required; Serve as department representative on cross-functional teams.
根據(jù)需要參與公司的內(nèi)部審計(jì)計(jì)劃；能夠擔(dān)任跨職能團(tuán)隊(duì)的部門代表；
6. Deal with quality events in the production department, including deviations, change control, CAPA, EC, risk assessments, etc.
處理生產(chǎn)部的質(zhì)量事件，包括偏差，變更，預(yù)防糾正措施，有效性檢查，風(fēng)險(xiǎn)評(píng)估等；
7. Lead the equipment validation and Re-qualification work
主導(dǎo)設(shè)備驗(yàn)證和再確認(rèn)工作。

Qualification 任職資格：

1. Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills.
能夠撰寫詳細(xì)的報(bào)告和總結(jié)，并展示注重細(xì)節(jié)的文檔技能；
2. Communicate effectively and work professionally in a team environment.
善于在團(tuán)隊(duì)中進(jìn)行有效的溝通和專業(yè)的工作；
3. Familiarity of computer-based systems.
熟悉計(jì)算機(jī)系統(tǒng)；
4. Oral and written communication skills in Chinese and English (Read, Write, Verbal).
良好的中英文讀寫和溝通能力；

5. Degree of junior college or above in Chemistry, Chemical Engineer, Life sciences or relevant background.
?？萍耙陨蠈W(xué)歷，化學(xué)、化學(xué)工程、生命科學(xué)或者相關(guān)專業(yè)；
6. Basic knowledge and understanding of biopharmaceutical technology, especially the process of monoclonal antibodies or recombinant fusion protein drugs.
對(duì)于生物制藥技術(shù)有一定了解，特別是單克隆抗體或者重組融合蛋白藥物的工藝流程。