崗位職責(zé):
Responsible for:
1.Contribute to new and improvement projects for good quality in the projects, including of creation of requirement specification, analysis of feature specification from vendor, and lead sub projects.
2.Coordinate equipment on-site installation (IQ/OQ)
3.Lead production process pre-studies and relevant validations/qualifications (PQ, PV).
4.Develop production process system from documentation (PMF, SOP, BPR, WI etc.) to execution.
5.Establish & keep on-time update of production process database.
6.Follow up process activities through daily monitoring.
7.Ensure sufficient trainings to shop-floor people.
8.Organize product and process investigation in case of deviation, propose and follow up corrective and preventative s.
9.Analyze production technical problems and quality deviations, lead improvement projects.
10.Analyze production efficiency and losses etc, to drive continuous improvement.
任職資格:
Education 教育背景:
Bachelor of science in pharmaceutical
Work experience工作經(jīng)驗:
At least 3 years working experience in a pharma or medical device manufacturing plant.
Played a role of process or production technology in manufacturing or engineering department.
Experience of sterilized liquid process.
Experience of validations
Competence and skills技能技巧:
Strong competence in production system.
Good skills in PC, MS office
Very good in GMP and ISO 13485
Familiar with Lean manufacturing: 5s, six Sigma, Value Stream Design and others


Others其它:
Very good English in speaking and writing,
German skills will facilitate your work a lot.
Target-oriented working,
Creative thinking,
Very communicative

德國費森尤斯集團是世界500強企業(yè)之一，為全球性的醫(yī)療保健服務(wù)公司，由五個在世界范圍內(nèi)獨立運作的事業(yè)部組成：費森尤斯醫(yī)藥用品、費森尤斯卡比、費森尤斯醫(yī)院、費森尤斯工程、費森尤斯生物技術(shù)。
費森尤斯醫(yī)藥用品有限公司事業(yè)部是當(dāng)今世界最大的慢性腎衰竭產(chǎn)品和服務(wù)的供應(yīng)商，是全球透析治療的領(lǐng)導(dǎo)者。
我們的目標：每天，為全世界的人們創(chuàng)造一個值得生活的未來。
江蘇費森尤斯醫(yī)藥用品有限公司是德國費森尤斯集團在中國投資的獨資企業(yè)。公司成立于2007年7月17日，位于常熟市古里工業(yè)園區(qū)。公司集研發(fā)和生產(chǎn)功能于一體，主要生產(chǎn)用于血液透析配套產(chǎn)品，產(chǎn)品主要面向國際市場銷售，部分產(chǎn)品面向國內(nèi)市場。目前總投資9402萬美元，員工1000多人。
由于公司不斷增加的新項目和訂單需求，現(xiàn)我們誠邀那些勤奮敬業(yè)、不斷超越自我的專業(yè)人才加入我們的團隊，共創(chuàng)偉業(yè)！
公司提供良好的培訓(xùn)和發(fā)展空間，同時您也可以領(lǐng)略到多國文化的和諧共處，提高自己的外語水平和國際視野。另外，公司還提供免費宿舍、免費工作餐及常熟市內(nèi)／蘇州班車、年底績效獎金、帶薪年假及其他歐美獨資企業(yè)待遇。