職位描述
POSITION SUMMARY（職位概述）
As the project leader from Plant/Operation function, work with RD, Marketing, RA and MA, Quality team for new products introduction and launch. Overall accountable for manufacturing activities coordination, planning and execution.
作為工廠項目負責人，與研發，市場，法務，醫務和質量部門合作負責完成新產品項目的導入和上市。負責統籌工廠運營部分的工作協調，計劃及執行。
KEYRESPONSIBILITIES（主要職責）
1) Responsible for operation NPI activities planning and team execution. Manage the on time completion on the DV, TT and Clinical trial samples manufacturing.
負責統籌工廠新產品導入工作計劃及執行，按時完成DV, 形式檢驗及臨床樣品的制造。
2) Plan and monitor the project spending and capital budget and in charge of budget commitments.
負責項目預算的制定和監控，并確保項目費用控制在預算范圍內。
3) Work with functional team on new product standard cost assessment.
評估新產品制造成本。
4) Coordinate the related documentation and audits from operation function for product registration.
協調產品注冊過程中的文檔和相關審核。
5) Coordinate with operation team members on the new production line/equipment installation, debugging and process validation.
協調工廠項目成員引進新產線/設備的安裝和調試及工藝驗證。
6) Performs any other task(s) as assigned, or defined in related quality procedure.
完成其他指定的工作或在質量文件中定義的職責。
SKILLSANDABILITIES（技能）
1) Education: Above College Degree.
大專以上
2) At least 3+ years’ related project management experience；Knowledge of new product development process;
至少3年以上相關項目管理經驗; 了解新產品開發流程
3) Knowledge of ISO9001,13485 and GMP criteria;
了解ISO9001, 13485和GMP 的相關標準；
4) Good inter-personal skills and ability to work cohesively within a multinational team in an international environment;
良好的溝通技巧，有在跨國公司工作背景。
5) Ability to learn quickly and adjust personally to changes in customer requirements.
能夠快速學習和自我調節來適應工作需要
6) Good computer skill and documentation skills(office word, excel, project, PPT)
熟練使用計算機, 文檔編輯能力（office word，excel, project, PPT）
