英文口語流利

有技術支持經驗（如產品研發，產品質量等），有新產品導入到量產全流程管理經驗

熟悉CAD，工藝，質量，生產等監控及跨部門溝通

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