微生物技术员岗位的主要职责英文
微生物技术员负责执行原辅料、包装材料、中间产品的取样。下面是本站小编整理的微生物技术员岗位的主要职责英文。
篇一
执行原辅料、包装材料、中间产品的取样
Raw materials, excipients and intermediate sampling
执行日常微生物相关的检验，包括微生物限度检查、细菌内毒素检查及无菌检查等
Perform routine microbial related analysis, including microbial limit test, endotoxin test and sterility test
水系统及洁净环境的日常监控
Water system and clean environment monitoring
培养基、菌悬液及其他实验相关试剂的制备
Preparation of culture media, buffer solution and microbial strain for testing
协助OOS/OOT/偏差的调查
Asist OOS/OOT/Non-compliance investigation
职位要求：
了解中国药典、美国药典、欧洲药典及GMP/cGMP/欧盟GMP的相关要求
Understand the ChP/USP/EP and the GMP/cGMP/EU GMP
熟悉无菌检查、微生物限度检查、细菌内毒素检查等药品微生物的检测及方法验证
Familiar with the sterility test/microbiology limit test/endotoxin test and also the TMV
熟练掌握细菌内毒素检测仪器、无菌检查隔离器、脉动真空灭菌柜、微生物鉴定仪等常用设备的使用
Familiar with the usage of common equipment such as endotoxin testing equipment, isolator, autoclave, ID detector, etc
篇二
Principle Job Accountabilities 工作职责描述
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
根据作业指导书按时完成相关微生物检验：水，产品和工厂环境，以确保产品符合法规和公司标准。
负责标识测试产品的检验状态，隔离任何不符合微生物标准的产品，防止不合格产品被使用。
根据作业指导书正确使用校准设备及时测试进货原材料，包材，过程材料，QA放行检验日常检验及特殊实验，以确保产品
质量符合公司的标准。
4.按照要求校准设备，确保符合公司作业指导书。
5.及时根据实验结果&最终决定在SAP中放行或冻结批次。
6.按照需要及时准备批次COA/COC。
7.根据需要在TW系统下发实验结果超标的偏差。调查检验结果超标是否与样品，设备，人员，方法等方面有关，如果发现检验结果超标与实验室有关，则需要快速采取措施。
8.确保所有文档完全完成,维护实验室日志和记录,以确保可追溯性。
9.根据需要改进测试方法，确保及时更新质量体系中的相关文件。
10.及时向实验室主管报告异常情况，确保及时将问题解决。
11.和相关部门及时沟通对检验有影响的问题 (设备，环境，样品等)。
12.负责进行内部审核，尤其是对微生物较敏感的区域。
13.负责培训微生物相关事宜以及GMP,5S, SOP等。
14.管理与完成微生物相关事项的所有资源，确保各项资源满足计划要求，并对哪些方面的资源未能达到相关要求提出建议。
15.持续进行专业改进确保保持现有的知识能满足对于医疗器械的微生物要求。
16.在RB***方法中的微生物方面进行输入，并向其他RB工厂学习，实施***方法。
17.履行环保责任，例如隔离废弃物和遵守GMPs的规定(良好的生产规范)，确保符合ISO 14001的要求。
18.必须遵守公司关于健康和安全的程序和政策，发现不安全因素立即报告，以确保安全的工作环境。
19.理解并遵守公司的环境、健康与安全政策和程序，理解工厂的相关目标。
20.完成分配到的其它任务。
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?
质量控制分析技术员-微生物技术员
工作职责：
根据SOP和相关的测试方法完成实验室日常检验，记录等工作;
负责纯化水样品，洁净间，氮气监测样品的取样
负责仪器验证，日常校准及维护工作;
协助或负责实验室OOS，DR调查工作;
维护实验室消耗品的管理，卫生工作以及文件管理工作;