QA Supervisor/Senior Specialist

09/04更新

潤雅生技股份有限公司本公司其他工作

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應徵

應徵人數 0~5 人

工作內容

This position is to maintain cGMP compliance. Primary Duties and Responsibilities, including mental requirements of position: • GMP documents review and approval. • Supervise and conduct supplier qualification program for vendors. • Supervise and conduct in-process, raw material and stability sampling. • Assist QA Management in managing deviation, investigation, CAPA systems, stability program and Quality Systems to comply with applicable regulatory requirements. • Review and create QA-related SOPs. • Miscellaneous tasks assigned by Management.

職務類別

、

工作待遇

待遇面議

（經常性薪資達 4 萬元或以上）

工作性質

全職

上班地點

新竹縣竹北市生醫五路19號

遠端工作

管理責任

不需負擔管理責任

出差外派

無需出差外派

上班時段

日班

休假制度

依公司規定

可上班日

不限

需求人數

1人

條件要求

工作經歷

3年以上

學歷要求

大學以上

科系要求

藥學相關、化學相關、生物學相關

語文條件

英文 -- 聽 /中等、說 /中等、讀 /中等、寫 /中等

擅長工具

不拘

工作技能

不拘

其他條件

• Degree or Master in biological Science • Solid Experience (minimum 3 years) in Aseptic environment • More than 5 years of relevant and current work experience in Biotech/ Pharmaceutical industry in Quality Assurance • Good knowledge of GxP regulations and guidelines, industry practices. • A team player with excellent interpersonal, organizational, and communications skills (verbal and written) • Good speaking and writing skills in both English and Mandarin. • Must be self-motivated, engaged and able to perform moderately complex tasks independently • Strong problem-solving skills • A broad understanding of Biopharmaceutical Sciences processes and Quality Systems is plus • Skilled at the use of Enterprise systems including, but not limited to site Quality Tracking System (QTS), Laboratory Information Management System (LIMS), SAP, TrackWise is plus. • Qualified Authorized Person is plus.

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