1. To be responsible for tech transfer on behalf of MFG USP/DSP. 代表上游/下游生產負責技術轉移； 2. Participate in the evaluation of new technology, new production process and new production technology. 參與評估新工藝、新生產流程和新生產技術； 3. Make project BOM per required; Draft MPI and BPR per the process. 根據要求起草項目BOM；根據工藝要求寫工藝規程和批記錄； 4. As the representative of the production department, handle material qualification and supplier qualification. 作為生產部的代表處理物料確認和供應商確認； 5. As a representative of the production department, respond to quality audits from the administrative supervision departments and customers. 作為生產部代表應對來自行政監管部門和客戶的質量審計； Participate in the internal auditing program for company as required; Serve as department representative on cross-functional teams. 根據需要參與公司的內部審計計劃；能夠擔任跨職能團隊的部門代表； 6. Deal with quality events in the production department, including deviations, change control, CAPA, EC, risk assessments, etc. 處理生產部的質量事件，包括偏差，變更，預防糾正措施，有效性檢查，風險評估等； 7. Lead the equipment validation and Re-qualification work 主導設備驗證和再確認工作。

Qualification 任職資格：

1. Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills. 能夠撰寫詳細的報告和總結，并展示注重細節的文檔技能； 2. Communicate effectively and work professionally in a team environment. 善于在團隊中進行有效的溝通和專業的工作； 3. Familiarity of computer-based systems. 熟悉計算機系統； 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. 專科及以上學歷，化學、化學工程、生命科學或者相關專業； 6. Basic knowledge and understanding of biopharmaceutical technology, especially the process of monoclonal antibodies or recombinant fusion protein drugs. 對于生物制藥技術有一定了解，特別是單克隆抗體或者重組融合蛋白藥物的工藝流程。