職位描述
POSITION SUMMARY（職位概述）
Plan and conduct micro analysis/test and documentation required by control plan/SOPs for raw materials, finished product, utilities, environmental and other necessary. Take main responsibility for micro analysis relevant implemented to meet corporate/ISO/GB/regulation/GMP requirements.
計劃、執行微生物實驗室分析和測試，包括原料、成品、公用設施、環境和其他必要的測試。確保相關微生物分析測試符合公司/ISO/GB/法規/GMP的要求。
KEY RESPONSIBILITIES（主要職責）
1. Set up the management rules to ensure the efficiency of laboratory work under the well compliance with the corporate/ISO/GB/regulation/GMP requirements.
建立微生物實驗室管理規程確保實驗室的有效運行，并符合公司/ISO/GB/法規/GMP的要求。
2. Perform qualification/validation/calibration and maintenance for analytical devices to ensure analytical devices in good status and GMP compliance.
執行分析設備/儀器的確認/驗證/校驗和維護以確保分析設備/儀器處于良好的狀態和GMP的符合性。
3. Plan and execute the microbiological limits test/sterility test/Endotoxin test method validation.
計劃和執行完成微生物限度檢查、無菌檢驗、細菌內毒素測試的方法驗證。
4. Perform and record microbiological testing for raw material, packaging material, products, stability, utilities, environmental sample by following Quality Specification /control plan, to provide accurate testing results on time
依據質量標準/檢驗計劃完成原料、包裝材料、產品、穩定性、公用設施、環境等的微生物測試，并及時提供準確的檢驗數據。
5. Handle chemical reagents, biological reference substances/standard strains and solutions appropriate to compliance with the regulations and SOPs, to keep safe and tidiness of working area.
依據法規和SOPs要求操作化學品、微生物參考物質/標準菌株、溶液等，確保實驗室安全和工作區域的整潔。
6. Cope with abnormities of the testing in time by reporting to the supervisor, or appropriate to the instruction of SOP.
及時調查實驗室測試異常結果的調查。
7. Leading and working on OOS investigation for microbial results of water/raw material, products.
領導水、原料、產品微生物檢驗的任何OOS的調查活動。
8. As a microbiological expert provide training to production, involve in relevant deviation investigation.
作為微生物專家給生產部提供相關微生物培訓、參與相關偏差調查。
9. Perform the annual products sterilization validation and report all the validation testing.
參與產品的年度滅菌確認并負責產品驗證時實驗的組織和結果的控制;
10. Plan and reviewing the inventory of reagent, glassware and miscellaneous items in microbiological laboratory and make order plans based on the budgets.
計劃微生物實驗室試劑、玻璃儀器、耗材的采購和維護適當的庫存管理。
11. Other work need to do.
任何其他安排的工作。
SKILLS AND ABILITIES（技能）
1. Above bachelor degree of microbiological, or relevant.
微生物或相關專業，本科或以上學歷畢業；
2. 3 years’ experience for micro analysis.
相關微生物工作經驗3年以上；
3. GMP/ISO13485 knowledge as basic for the role
具備GMP/ISO 13485相關知識
4. Good communicate and learning skill.
良好的溝通技巧、學習能力；
5. Skill of Microsoft office .
電腦辦公軟件應用熟練；
6. Skill of English in reading and writing.
有一定的英語讀寫能力。
7. With or be trained Pressure Vessel Operation Certificate preferred
持有壓力容器操作證，或經相關培訓
