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Overall Objectives of the Position 職位目標

· To perform a range of standard and specialized laboratory experiments, using both standard and specialized laboratory equipment, presenting and contributing to the interpretation of results in biological lab

使用標準和專業實驗室設備進行一系列實驗室測試，在生物實驗室提供實驗結果并作出相應的解釋。

· Provide support for laboratory running such as management of reagents, reference standards, reference strains, Instrument Routine Maintenance, HSE, documentation (SOP / Work Instruction / testing monograph / primary record, etc) and other activities in biological lab

為實驗室運行提供支持，如試劑管理、參考標準、儀器日常維護、HSE、文件（標準操作規程/工作指導/測試方法/原始記錄等）和生物實驗室的其他活動。

Main Tasks 主要職責

· Perform laboratory tests (such as Cell growth test, Cell Thawing, Cell Passing, Freezing Cells, Cell counting, Cell Adaptation, cell bank management, EM, Microbial limit test, sterility test, endotoxin test, cell culture test and simple physical and chemical test) through operating standard and specialized laboratory equipment in accordance with SOPs, working instructions procedures and testing monographs, and document properly in a timely manner.

按照相應的標準操作規程、工作指導書和測試方法進行實驗室測試（如細胞生長測試、細胞凍存、細胞傳代、細胞適應性、環境監測、微生物限度檢測、無菌檢測、細菌內毒素、細胞培養和基本的理化檢測），并及時妥善記錄。

· Responsible for sampling of in-coming goods including packaging material, water, responsible for sampling room running and maintenance.

負責來料取樣，包括原料包材、水；負責取樣間的運行與維護。

· Perform lab equipment qualification/calibration, method transfer and validation analytics assigned.

根據方案進行實驗室設備確認、方法轉移和驗證。

· Contribute to problem solving associated with laboratory work such as OOT/OOS/DEV investigation.

致力于解決與實驗室工作相關的問題，例如OOT/OOS/DEV 調查。

· Maintain high level of safety, environmental protection and housekeeping in all laboratory operations, comply to relevant Quality System cGMP requirement. Contribute also in the system establishment.

在所有實驗室操作中保持高水平的安全、環境保護和內務管理，遵守相關的質量體系 cGMP 要求。也為系統的建立做出貢獻。

· Strictly comply with company EHS safety regulations and master skill of safety work and emergency rescue knowledge.

嚴格遵守公司EHS的安全規定，掌握安全工作技能和應急救援的知識。

· Take responsibilities in assigned projects as appropriate.

在分配的項目中適當承擔相應的責任。

· Be a valuable team member of Quality organization and develop self and others (e.g. junior lab staff/new comer training) through close teamwork and cross functional/sectional activities. Be a continuous improver.

成為質量組織中有價值的團隊成員，通過緊密的團隊合作和跨職能/跨部門活動發展自我和他人（例如初級實驗室工作人員/新人培訓），持續改進。

· Maintain and control Biological-lab consumable, microbiological media, strains and biological indicator.

維護和控制生物實驗室的耗材、微生物培養基、菌種和生物指示劑。

· Actively participate in quality culture building and quality related activities

積極參與工廠的質量文化建設和質量相關活動

· Actively report quality related events and participate in continuous quality improvement activities

主動匯報質量相關事件，積極參與工廠的質量持續改進的活動

· Maintain the high GMP compliance and DI for Bio QC lab

將生物實驗室維持在一個較高的GMP和DI水平

· Contribute to digital visualization

致力于數字可視化工作

Education and Qualification Required 教育背景及任職要求

· Education:

College or University level. (Microbiology, Biochemistry, pharmaceutical, food etc.)

學院或大學水平。（微生物學、生物化學、制藥、食品等）

· Working Experience:

1. Attainment of qualified/responsible person status under local/international legislative requirements.

根據當地/國際立法要求獲得合格/負責人身份。

2. At least 3 years of Micro biological tests experiences in QC lab (experience in biological lab will add value). Familiar with CHO, HEK293 and Vero cell. SAP experience will add value.

至少3年QC實驗室微生物檢測經驗（有生物實驗室經驗者優先），熟悉CHO、HEK293和Vero細胞、SAP者優先。

3. Cross-functional working environment.

跨職能工作環境

4. Team working.

團隊協作

· Technical & Professional Knowledge:

1. Local language, Basic English speaking, good English reading and understanding

當地語言，基礎英語口語，閱讀和理解能力。

2. Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook)

熟練使用辦公應用軟件（MS-Word、MS-Excel、MS-Outlook）

3. Be able to work independently

能夠獨立工作

4. Perform the analysis work within cGMP environment and minimize laboratory errors.

在cGMP環境下進行分析工作，盡量減少實驗室錯誤。