高階主管

國光生技實行QbD品質源於設計理念

深化品管體系與製程開發優勢

藉由精準控管每一環節

提升製程效率與產品開發能力,接軌國際

品質源於設計(Quality by Design, QbD)是一項全球性的生技製藥法規監管倡議,主要目的是透過主動設計與控制製造過程,來推動生物製藥發展,從而穩定地提供符合預期的高品質產品,以確保每一批產品的安全性與療效。QbD也是美國FDA和ICH(國際醫藥法規協和會)對生技製藥業的概念性規範。

國光生技歡迎高階生產、製造及熟悉國際市場的專業經理人加入

Adimmune implements Quality by Design (QbD) to strengthen our quality systems and process development. Enhancing process efficiency and product development through precise control at every stage, Adimmune continues to align with international standards.

QbD is a global regulatory initiative in the biopharmaceutical industry, aimed at proactively designing and controlling the manufacturing process to ensure consistent delivery of high-quality products as well as the safety and efficacy of every batch. QbD is a conceptual framework advocated by both the U.S. FDA and the International Council for Harmonisation (ICH).

Adimmune welcomes senior professionals with expertise in production, manufacturing, and international market operations to join our team.