Principal Accountabilities (Major end results the job is expected to achieve)
主要工作職責(主要工作成就,期望此職位達到的目標)
?To perform media preparation to ensure all media and reagents are available for routine testing
執行培養基配製工作,確保日常監測需要的培養基和試劑可以獲得
?Be involved in the routine test and stability test
執行常規的微生物測試和穩定性測試
?Perform PW and environmental monitoring
純化水和環境監測工作
?Be responsible for lab equipment calibration/ qualification/ validation activities
校驗,確認和維護微生物實驗室設備
?Support test method and other process validation (e.g. cleaning validation and EM validation)
支持或者執行檢驗方法和工藝驗證(如清潔驗證和環境驗證)
?Be responsible for the sample receiving and management of retaining sample, consumable and reagent
負責樣品接收和管理留樣、易耗品和試劑
?Be responsible for the stock management
負責庫存管理
?Ensure working in accordance with cGMP/HSE guidelines and Quality standards at all time.
確保時刻遵循cGMP , 安全和質量的要求
?Support change controls, CAPAs and OOS investigations.
協助變更控制、CAPA和偏離規格調查
?Be involved in lab special optimization project if needed
需要時,參與實驗室優化項目
?Work as a collaborative team member
團隊合作
?Other tasks assigned by the supervisor
主管分配的其他工作
Job Context / Key Challenges
工作內容/主要的挑戰
?Control and management of consumables and media in laboratory
實驗室耗材和培養基的管理和控制
?Supports manufacturing and QA in providing testing activities in accordance to the testing requirements as per the product files.
根據產品測試要求為生產和QA提供測試
?Ensure timely completion of product testing
確保及時完成產品的測試
?Identification of optimization activities during the laboratory working process
識別工作過程中的可優化活動
Dimensions (Relevant facts and figures relating to job)
職責範圍(與此職位相關的事務與指標)
Management of laboratory inventory and consumables
管理實驗室庫存和易耗品
Trouble shooting of any OOS/OOT issues
對超標和異常的事件進行問題分析
Knowledge and Experience (Knowledge and experience needed for satisfactory performance of the job)
資質和經驗(此職位所要求的資質和經驗)
Essential 主要的
Education-graduated from a technical secondary school in microbiology or related field.
教育 - 微生物或相關專業中專以上學歷
Experience- One year or above work experience in microbiology lab.
經驗 - 1年或以上微生物實驗室工作經驗
Good communication and responsibility.
良好溝通技巧和責任感
Desirable 額外的
Experience in the Medical device
醫療器械行業經驗
Experience of working in a foreign owned company
外企工作經驗
職位描述: