Salary & Location
Salary negotiable
(Regular monthly salary of NT$40,000 or above)
桃園市龍潭區
Required
Language Requirements
English
聽/精通、說/精通、讀/精通、寫/精通
Work Experience
3年以上
Job Description
1.Validation master plan/report (Oral)
Process/Cleaning/Packaging/Shipping validation
Equipment performance qualification
Technical Transfer
Process capability annual review
Risk assessment
SOP revision/training
Change control (process related)
GMP Inspection as validation SME
Operation excellence
2.Process improvement
3.Trouble shooting
4.Investigation
• At least 3 years of pharmaceutical industry experience in process development/validation for aseptic and/or solid oral dosage form; compliance knowledge and technical expertise in pharmaceutical industry.
• Able to adapt changing environments and work processes.
• Experience in project management, communication and problem-solving skills
• English writing and presentation skills
Number of Openings
1~1人
Educational Requirements
大學(學院)以上
Field of Study Requirements
自然科學學科類、醫藥衛生學科類、工程學科類
Work Schedule
日班
Leave Policy
週休二日
Job Category
Biotechnology Research and Development Staff
Pharmaceutical Research and Development Staff
Chemical Engineering Research and Development Staff
桃園市龍潭區
藥品製造業
祥翊製藥股份有限公司創立於西元2014年，整合API與製劑專業能力與研發能量，開啟口服及針劑產品的專案研發，於2017年在美國上市第一個學名藥產品；同時亦於龍潭科學園區建立自有廠房，西元2019年龍潭廠設施成功順利通過TFDA及FDA審查合格，陸續有數個產品在美國上市，實踐祥翊「在地生產、進軍國際」的雄心壯志。
本公司經營團隊在製藥產業服務多年，在原料藥製程開發、製劑配方開發、製程放大生產、品管與GMP、DMF與ANDA註冊、業務開發與行銷、及公司經營方面累積多年經驗；將應用累積的專長與經驗，從事505(b)2新藥與高端學名藥之開發。
我們重視每一位員工，除了有良好工作環境、也提供學習及成長的空間，歡迎優秀的朋友一起加入祥翊製藥股份有限公司的工作行列。
