職位概要(Job summary): 

管理公司內部的微生物實驗室和化學實驗室，組織完成醫療器械的檢驗工作，確保檢驗結果的準確性和有效性。主要工作包括對產品、環境、原材料、內包材、工藝用水等進行無菌檢查、微生物限度檢查、細菌內毒素檢查。
Manage the internal microbiology laboratory and Chemical laboratory of the company, organize the completion of medical device inspection work, and ensure the accuracy and effectiveness of inspection results. The main responsibilities include conducting aseptic testing, microbial limit testing, and bacterial endotoxin testing on products, environment, raw materials, internal packaging materials, process water, etc.

工作職責(Responsibilities):  

1.	實驗室管理：負責微生物實驗室和化學實驗室的日常管理和運營，確保實驗室各項工作符合GMP、藥典和其他相關法律法規，以及公司質量體系等的相關要求。 
Laboratory Management: Responsible for the daily management and operation of Microbiology and Chemical laboratories, ensuring that all laboratory work complies with GMP, pharmacopoeia, and other relevant laws and regulations, as well as company quality management system and other related requirements.
2.	文件管理：負責起草、修訂相關文件，并對現有文件提出改進及優化，確保實驗室管理的規范化和標準化。 
Document management: Responsible for developing and revising relevant documents, and provide improvement and optimization for existing documents to ensure the standardization and normalization of laboratory management.
3.	方法驗證：對新產品進行檢驗方法的摸索及方法學驗證，確保檢驗方法的科學性和可靠性，包括無菌檢查、微生物限度檢查、細菌內毒素檢查等方法的開發、驗證和實施。
Method validation: Develop and validate the testing methods for new products, ensuring the scientific and reliable nature of the testing methods, including the development, validation, and implementation of methods such as sterility testing, microbial limit testing, and bacterial endotoxin testing.
4.	檢驗任務：負責微生物實驗室和化學實驗室的檢驗任務，包括對產品、原材料、內包材、環境、工藝用水等的無菌、微生物限度、內毒素、陽性實驗和菌種鑒定， 以及對產品的不溶性微粒檢測和EO/ECH殘留檢測、對工藝用水的化學檢驗等。
Inspection tasks: Responsible for the inspection tasks of microbiology laboratory and chemical laboratory, including sterility, microbial limits, endotoxins, positive experiments and strain identification of products, raw materials, internal packaging materials, environment, process water, etc., as well as insoluble particle detection and EO/ECH residue detection of products, chemical inspection of process water, etc.
5.	環境監測：負責潔凈區的環境監測計劃的制定及日常監測，統計和分析數據。
Environmental Monitoring: Responsible for environmental monitoring plans for clean areas, conducting daily monitoring, and collecting and analyzing data.
6.	團隊管理：負責對檢驗人員進行崗位培訓和技術指導、監督、管理 。 
Team management: Responsible for providing job training, technical guidance, supervision, and management to inspection personnel.
7.	設備管理：參與微生物實驗和化學實驗相關的儀器設備及計算機化系統的驗證及管理工作。 
Equipment management: Participate in the validation and management of instruments, equipment, and computerized systems related to microbiological and chemical experiments.
8.	物料管理：負責實驗室的各類物料管理，包括樣品、菌種、生物指示劑、培養基、試劑耗材等。
Material Management: Responsible for managing various materials in the laboratory, including samples, strains, biological indicators, culture media, reagents, consumables, etc.
9.	數據分析和異常處理：對關鍵檢測數據進行定期的趨勢分析，對相關檢驗過程中出現的偏差、OOS/OOT等實驗室異常的調查處理。
Data analysis and anomaly handling: Conduct regular trend analysis on key detection data, investigate and handle laboratory anomalies such as deviations and OOS/OOT that occur during the relevant inspection process.

任職資格(Qualification) :
1. 教育背景：全日制本科及以上學歷，生物工程、微生物、醫藥、應用化學等相關專業。 
Education background: Full time bachelor's degree or above, major in biotechnology, microbiology, medicine, applied chemistry, or related fields.
2. 工作經驗：5年及以上相關醫療器械行業微生物實驗室工作經驗，熟悉中美歐GMP和CHP/USP/EP藥典對無菌和微生物控制的相關技術和方法要求，包括微生物限度檢查、無菌檢查、細菌內毒素檢查等，能夠獨立編寫微生物相關SOP、方案報告; 熟悉各類檢驗儀器的使用和維護； 有醫療器械無菌檢驗員證書。
Work experience: more than 5 years relevant experience in microbiology laboratories in the medical device industry, familiar with the technical and methodological requirements for sterility and microbiological control in the GMP and CHP/USP/EP pharmacopoeias of China, the United States, and Europe, including microbiological limit testing, sterility testing, bacterial endotoxin testing, etc., Able to independently write microbiology related SOPs, protocol and reports; Familiar with the use and maintenance of various inspection instruments; Has a certificate as a sterile inspector for medical devices.
3. 技能要求：有團隊管理經驗，具備良好的組織管理、計劃、協調和溝通能力，問題分析和解決能力，能夠有效地管理團隊和實驗室的日常運營；需要具備風險規避和防范意識，確保實驗室工作的安全和質量 。
Skills required: Have team management experience, good organizational management, planning, coordination, and communication skills, problem analysis and resolution abilities, and be able to effectively manage the daily operations of teams and laboratories; Risk avoidance and prevention awareness are required to ensure the safety and quality of laboratory work.
4. 英語技能：CET-4以上，具備英文聽說讀寫能力，能閱讀國外藥典和標準。
English skills: CET-4 or above, with English listening, speaking, reading, and writing abilities, able to read foreign pharmacopoeias and standards.