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吳睿鏞
副主任
1.標準作業程序修訂/整合/新增以符合PIC/s GMP規範、使作業流暢
2.與研發部門溝通完成製程瓶頸突破、完成設備優化。
3.完成無菌製程模擬、製程、設備確效、與產品安定性試驗
4.與確效部門合作撰寫設備URS、3Q驗證
5.變更管制處理與預防改正行動
6.設備、儀器故障搶修、預防保養管理
7.部門內儀錶校正與管理
8.耗材管理
9.生產排程訂定與管理
永昕生物醫藥股份有限公司
嘉義大學
台灣台中市
Professional Background
- Current status
- ProfessionOther
- FieldsPharmaceutical / Biotech
- Work experience6-10 years (6-10 years relevant)
- ManagementI've had experience in managing 10-15 people
- Skills
- LanguagesChinese・Native or BilingualEnglish・Beginner
- Highest level of educationBachelor
Job search preferences
- Desired job typeFull-time・Interested in working remotely
- Desired positions
- Desired work locations
- FreelancePart-time freelancer
Work Experience
副主任
1.針劑生產部標準作業程序修訂/整合/新增以符合PIC/s GMP規範、使作業流暢
2.無菌充填製程瓶頸突破、完成設備優化。
3.完成無菌製程模擬、設備確效、與產品安定性試驗
4.撰寫設備URS、3Q驗證
5.變更管制處理與預防改正行動
6.設備、儀器故障搶修、預防保養管理
7.部門內儀錶校正與管理
8.耗材管理
9.完成代工製程放大與生產瓶頸突破
10.2021/05/11順利通過TFDA查廠-無菌產品之固體劑型：凍晶乾燥注射劑、無菌產品之液體劑型：注射液劑（小容量）
製造課長
1.部門內標準作業程序重新修訂以符合PIC/s GMP規範。
2.拆分批次紀錄，依製程區分，使批次紀錄快速結案，快速放行。
3.開發新劑型，完成設備優化。
4.完成製程、設備確效、與產品安定性試驗
5.鼻吸薄荷棒製程優化與製造
6.生產排程訂定管理
7.撰寫設備URS、3Q驗證
8.變更管制處理與預防改正行動
9.人員再教育訓練
工程師
1.Preparation & execution of Buffer solutions .
2.Equipment Qualification documentations: URS, Installation/ Operation/ Performance Qualification of clean booth, cold cabinet.
3.Preparation of GMP Standard Operation Procedure.
4.Validation Activities:Process Validation of Module100, Clean Validation of Process Equipment, Environmental Cleaning Validation.
5.Inspection Experiences: TFDA, EMEA, FDA