微生物技術員崗位的主要職責英文

微生物技術員負責執行原輔料、包裝材料、中間產品的取樣。下面是本站小編整理的微生物技術員崗位的主要職責英文。

篇一

執行原輔料、包裝材料、中間產品的取樣

Raw materials, excipients and intermediate sampling

執行日常微生物相關的檢驗，包括微生物限度檢查、細菌內毒素檢查及無菌檢查等

Perform routine microbial related analysis, including microbial limit test, endotoxin test and sterility test

水系統及潔淨環境的日常監控

Water system and clean environment monitoring

培養基、菌懸液及其他實驗相關試劑的製備

Preparation of culture media, buffer solution and microbial strain for testing

協助OOS/OOT/偏差的調查

Asist OOS/OOT/Non-compliance investigation

職位要求：

瞭解中國藥典、美國藥典、歐洲藥典及GMP/cGMP/歐盟GMP的相關要求

Understand the ChP/USP/EP and the GMP/cGMP/EU GMP

熟悉無菌檢查、微生物限度檢查、細菌內毒素檢查等藥品微生物的檢測及方法驗證

Familiar with the sterility test/microbiology limit test/endotoxin test and also the TMV

熟練掌握細菌內毒素檢測儀器、無菌檢查隔離器、脈動真空滅菌櫃、微生物鑑定儀等常用設備的使用

Familiar with the usage of common equipment such as endotoxin testing equipment, isolator, autoclave, ID detector, etc

篇二

Principle Job Accountabilities 工作職責描述

Timely performs microbiological testing according to work instructions on water, product, and the factory environment to ensure compliance to regulatory and company standards.

Has the authority and responsibility to timely quarantine and label material or product that fails microbiological specifications in order to ensure that non-conforming material or product is not used or released.

Using calibrated equipment timely performs routine testing of in-coming raw materials and packing materials, in-process materials, QA final releasing test and other special test to ensure compliance to company standards.

Calibrate equipment as required to ensure compliance to company work instructions.

Release or block the batch in SAP based on the testing results & final decision timely.

Preparation of batch COC & COA for releasing timely.

Issue deviation in TW system for lab OOS as required and investigate lab OOS in terms of sample, equipment, personnel, method etc., Take quick actions for the lab related findings.

Ensure that all documentation is fully completed – maintains laboratory logs and records to ensure traceability.

Develop new test methods as required and ensure the timely updating of Quality System documentation

Timely reports to QA lab supervisor any abnormal issues to ensure timely resolutions

Communicate with related department for shift issue (equipment, environment, sample etc.,) that has impact to testing timely.

Responsible for performing internal audits especially in regard to areas that are microbiological sensitive

Responsible for training staff in regard to microbial issues and GMP, 5S, SOPs, etc.

Manage all resources associated with the completion of microbiological activities to agreed schedules and highlight and make proposals to management where resources do not match requirements.

Ensure continued professional development to maintain current knowledge on microbiological requirements for medical devices and aqueous products

Input into RB best practice forums regarding microbiological activities and implement best practice from other RB sites.

Must perform environmental duties such as segregation of waste and following GMPs (Good Manufacturing Practices) in order to comply with ISO 14001.

Must comply with company health and safety procedures and policies and must immediately report any unsafe condition to ensure a safe workplace.

Must comply with company health and safety procedures and policies and must immediately report any unsafe conditions Understand and comply with company environmental and health and safety policies, and procedures. Understands site objectives.

Any other duties commensurate with the level and scope

根據作業指導書按時完成相關微生物檢驗：水，產品和工廠環境，以確保產品符合法規和公司標準。

負責標識測試產品的檢驗狀態，隔離任何不符合微生物標準的產品，防止不合格產品被使用。

根據作業指導書正確使用校準設備及時測試進貨原材料，包材，過程材料，QA放行檢驗日常檢驗及特殊實驗，以確保產品

質量符合公司的標準。

4.按照要求校準設備，確保符合公司作業指導書。

5.及時根據實驗結果&最終決定在SAP中放行或凍結批次。

6.按照需要及時準備批次COA/COC。

7.根據需要在TW系統下發實驗結果超標的偏差。調查檢驗結果超標是否與樣品，設備，人員，方法等方面有關，如果發現檢驗結果超標與實驗室有關，則需要快速採取措施。

8.確保所有文檔完全完成,維護實驗室日誌和記錄,以確保可追溯性。

9.根據需要改進測試方法，確保及時更新質量體系中的相關文件。

10.及時向實驗室主管報告異常情況，確保及時將問題解決。

11.和相關部門及時溝通對檢驗有影響的問題 (設備，環境，樣品等)。

12.負責進行內部審核，尤其是對微生物較敏感的區域。

13.負責培訓微生物相關事宜以及GMP,5S, SOP等。

14.管理與完成微生物相關事項的所有資源，確保各項資源滿足計劃要求，並對哪些方面的資源未能達到相關要求提出建議。

15.持續進行專業改進確保保持現有的知識能滿足對於醫療器械的微生物要求。

16.在RB***方法中的微生物方面進行輸入，並向其他RB工廠學習，實施***方法。

17.履行環保責任，例如隔離廢棄物和遵守GMPs的規定(良好的生產規範)，確保符合ISO 14001的要求。

18.必須遵守公司關於健康和安全的程序和政策，發現不安全因素立即報告，以確保安全的工作環境。

19.理解並遵守公司的環境、健康與安全政策和程序，理解工廠的相關目標。

20.完成分配到的其它任務。

篇三

Our vision:

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission:

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.

Do you want to help us as we shape the future of this great organization?

質量控制分析技術員-微生物技術員

工作職責：

根據SOP和相關的測試方法完成實驗室日常檢驗，記錄等工作;

負責純化水樣品，潔淨間，氮氣監測樣品的取樣

負責儀器驗證，日常校準及維護工作;

協助或負責實驗室OOS，DR調查工作;

維護實驗室消耗品的管理，衞生工作以及文件管理工作;