Investors

Department Responsibilities

Department

Job Assignment

Audit

(1) Review and evaluate the soundness, reasonableness, effectiveness and implementation of the internal control system of each department.

(2) Implementation of the annual audit plan.

(3) Audit report writing and improvement operation assessment and internal control system self-inspection operation.

(4) Other actions in accordance with the law.

Production Department

(1) Process scale-up and process improvement for GMP-regulated cell culture and purification.

(2) Pharmaceutical preparation filling, packaging and labeling, etc.

(3) Management of upstream and downstream production, pharmaceutical production, equipment engineering and warehousing.

(4) Design of manufacturing process and introduction of production technology for pharmaceutical products.

(5) Development of pharmaceutical manufacturing specifications and processes.

(6) Evaluation and analysis of production cost of pharmaceutical process technology.

(7) Planning and execution of mass production testing of pharmaceutical products.

(8) Design, construction and maintenance of production sites.

Finance and Administration Department

(1)財務部

A.公司資金運用規劃、調度及管理。

B.資金預算之編輯、執行及管理。

C.長短期投資作業。

D.會計制度之擬定、執行與修訂。

E.財務報表、稅務報表之編制,向主管機關申報作業。

F.管理會計報表、財務分析報表之編輯。

G.董事會、股東會之籌辦及作業執行。

(2)管理部

A.新進員工之核薪、勞健保、對保、人員資料建檔等作業。

B.固定資產之帳務管理。

C.員工出缺勤、請假、出差等統計作業及薪資表編列。

D.固定資產設備、雜項設備之購置、列帳、報廢、出售等。

E.電腦軟體及硬體之管理及維護。

F.資訊系統之建置及安全管理。

(3)法務部

A.監督及覆核重大合約之條文訂定。

B.董事會、股東會之籌辦及作業執行。

R&D Department

(1)培養、純化、劑型設計。

(2)研究製程放大與改善。

(3)後續新產品與新技術之研究發展與評估。

(4)確保研發及所生產藥品符合FDA之cGMP要求。

(5)負責公司產品的GMP認證及品質管理工作。

Clinical Department

(1)依優良臨床試驗準則(Good Clinical Practice;GCP)推動臨床試驗,確認臨床試驗之品質與正確性。

(2)與多國多中心同步執行實驗,協調及確保實驗之一致性。

(3)設計試驗計劃書、個案報告表及試驗相關工作文件。

(4)舉行臨床試驗主持人會議和研究護士訓練。

(5)管理臨床試驗用藥。

(6)緊密檢測、稽核臨床實驗之進行,通報(嚴重)藥物不良事件。

(7)編寫臨床試驗報告。

(8)新藥開發與藥物送審法規研究。

(9)臨床許可申請與藥證申請。

(10)與各國藥物管理單位聯繫。

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