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(xiàng)目負(fù)責(zé)人，與研發(fā)，市場(chǎng)，法務(wù)，醫(yī)務(wù)和質(zhì)量部門合作負(fù)責(zé)完成新產(chǎn)品項(xiàng)目的導(dǎo)入和上市。負(fù)責(zé)統(tǒng)籌工廠運(yùn)營(yíng)部分的工作協(xié)調(diào)，計(jì)劃及執(zhí)行。
KEYRESPONSIBILITIES（主要職責(zé)）
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(fù)責(zé)統(tǒng)籌工廠新產(chǎn)品導(dǎo)入工作計(jì)劃及執(zhí)行，按時(shí)完成DV, 形式檢驗(yàn)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(fù)責(zé)項(xiàng)目預(yù)算的制定和監(jiān)控，并確保項(xiàng)目費(fèi)用控制在預(yù)算范圍內(nèi)。
3) Work with functional team on new product standard cost assessment.
評(píng)估新產(chǎn)品制造成本。
4) Coordinate the related documentation and audits from operation function for product registration.
協(xié)調(diào)產(chǎn)品注冊(cè)過程中的文檔和相關(guān)審核。
5) Coordinate with operation team members on the new production line/equipment installation, debugging and process validation.
協(xié)調(diào)工廠項(xiàng)目成員引進(jìn)新產(chǎn)線/設(shè)備的安裝和調(diào)試及工藝驗(yàn)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(zhì)量文件中定義的職責(zé)。
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(guān)項(xiàng)目管理經(jīng)驗(yàn); 了解新產(chǎn)品開發(fā)流程
3) Knowledge of ISO9001,13485 and GMP criteria;
了解ISO9001, 13485和GMP 的相關(guān)標(biāo)準(zhǔn)；
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(guó)公司工作背景。
5) Ability to learn quickly and adjust personally to changes in customer requirements.
能夠快速學(xué)習(xí)和自我調(diào)節(jié)來(lái)適應(yīng)工作需要
6) Good computer skill and documentation skills(office word, excel, project, PPT)
熟練使用計(jì)算機(jī), 文檔編輯能力（office word，excel, project, PPT）
