職位描述
協助QC 經理建立化學實驗室并維護實驗室的日常運行
Assist QC Manager to establish the new chem. lab and maintain the routine operation of chem. Lab
起草，復核或更新相關的SOP，檢驗方法和質量標準
Prepare, review and updated related SOPs, test method and specifications
起草儀器的確認方案，實施儀器的確認試驗并完成確認報告，例如化學實驗室儀器的安裝/運行/性能確認和再確認
Prepare the qualification protocol, conduct the qualification activities for equipments and complete the qualification report, such as IQ/OQ/PQ or re-qualification for chem. Lab equipment.
參與技術轉移工作，實施分析方法轉移并完成分析方法轉移報告
Participate the technical transferring ，conduct the analytical method transferring work and complete the analytical method transferring report
起草分析方法驗證/確認方案，實施相關測試，完成驗證/確認報告，例如工藝驗證，清潔驗證，藥典方法確認等
Prepare the analytical method validation/verification protocol, conduct the related testing and finish the validation report, such as process validation, cleaning validation, pharmacopeia test method verification etc.
作為實驗室計算機系統的本地管理員，清潔，維護試驗儀器，聯系供應商或合適的承包商完成儀器的確認或校驗，以確保儀器設備處于良好狀態
As local administrator of laboratory computerized system, Clean， maintain the equipments and contact with supplier or proper contractor to qualify/calibrate the equipments to keep in good status.
作為試劑管理員和對照品管理員協助化學實驗室耗材管理，包括試劑，對照品，玻璃儀器，個人防護用品等
Assist in As administrator of reagent and reference standard, management of chemical lab consumables, including reagents, reference standards, glassware, PPE etc..
復核檢驗記錄，必要時協助OOS 調查
Perform analytical record double checking and assist in OOS investigations when necessary.
起草新員工的培訓方案和確認計劃并實施培訓
Prepare the new staff training plan and qualification plan for new staff and conduct the training.
協助SHE 管理，確保試驗室各項活動符合公司SHE 的政策
Assist in SHE management to keep the lab to be in conformity with company SHE policy.
完成其他指定工作
Complete other assigned tasks
GMP 符合性
GMP compliance
嚴格執行化學室的相關標準作業程序和規章制度
Follow related SOPs and regulations strictly in chemical lab.
及時按照SOP 的要求填寫相關文件記錄如批化驗記錄、儀器使用和維護記錄等并保證內容的準確性
Fill in related documentation such as BAR, other logbook etc., timely to ensure the accuracy of content as per requirement of SOPs.
積極參加對自檢中所發現缺陷的整改
Take part in actively in correction to the observations found in self-inspection.
勝任能力COMPETENCIES
基本的分析化學知識；設定高目標并通過持續改進專業技能扮演國際化的角色；接受持續的培訓去開拓新的分析領域
Have basic analytical chemistry knowledge and set high goal to improve professional skills to meet the requirement as ainternational role; receive continuous training to explore new analytical areas.
客戶第一
Customer focus
任何行動都基于滿足內外客戶的基本需求；發展并維持高效的客戶關系
Make both internal and external customers and their needs a primary focus of one’s actions; develop and sustain productive customer relationships.
團隊精神
Team work
展現出強烈的意愿同來自部門內部同事或外部同事為了共同的目標而緊密工作的精神
Show strong willingness to work closely with peers within own unit or colleagues from other unitstoward a common goal.
結果為導向
Result oriented
為組織的成功和個人的貢獻建立挑戰性的目標；努力實現或超越目標
Establish stretched goals for organization successand personal accomplishments; strive to meet or exceed those goals.
學習和適應能力
Learning /adaptability
