英文口語(yǔ)流利
英文口語(yǔ)流利
有技術(shù)支持經(jīng)驗(yàn)(如產(chǎn)品研發(fā),產(chǎn)品質(zhì)量等),有新產(chǎn)品導(dǎo)入到量產(chǎn)全流程管理經(jīng)驗(yàn)
熟悉CAD,工藝,質(zhì)量,生產(chǎn)等監(jiān)控及跨部門(mén)溝通
Responsibilities
1.Support product transfer within pilot/ramp-up or mass-production sites by completing relevant PS activities
2.Perform design verification and report, provide internal training of product, material and end-user knowledge
3.Cooperate with relevant RA and QA to ensure design control and product meet the quality and regulation standard
4.Apply risk management and support on maintain risk management files
5.Give input to PMS (post-market surveillance) reports and participate in Product Review meetings if relevant
6.Create and maintain specifications, product description and composition (PDC) documents
7.Handle relevant activities in Change Control and update Manufacturing Flow Chart
8.Approve stability, transportation studies/reports and product drawings
9.Contribute to DHF/DMR and project documentation with essential PS knowledge
10.Analyse product performance (against intended use) and conduct comparison tests against competitors’ products
Qualifications
1.Bachelor’s degree in relevant technical background, e.g. Engineering, Pharmaceutical or Life Science (organic Chemistry or
applied chemistry is preferred)
2.At least 3 years of technical support experience or equivalent experience in relevant R&D, Quality or RA function