微生物环境监测检验员
浙江天元生物药业有限公司
- 公司性质:合资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2013-09-18
- 工作地点:杭州
- 招聘人数:1
- 工作经验:二年以上
- 学历要求:本科
- 职位类别:生物工程/生物制药 质量检验员/测试员
职位描述
? Perform testing of samples including EM, and Utilities.进行包括环境监测取样。
? Perform growth promotion testing, and microbiological identification.进行生长促进测试和微生物鉴定
? Assist in performing sterility and bioburden testing, as needed必要时协助进行无菌和生物负荷测试
? Issue excursion notices and assist in investigating root causes.发布异常情况报告,协助进行原因调查
? Responsible for the preparation and updating of SOPs governing the environmental monitoring, utility testing, growth promotion testing and identification methods.负责环境监测、生长促进测试和鉴定方法相关的SOP的起草和更新
? Train other analysts in job functions and assays, as needed.必要时对其他检验员的进行岗位技术培训
? Train manufacturing operators in environment monitoring sampling, as needed.必要时对生产操作员进行环境监测抽样的培训
? Collect trend data and author trend reports.收集趋势数据并发布
? Review EM and Utility monitoring documentation as a peer reviewer.审核环境监测文件
? Execute EM and Utility Method validations.执行EM验证
? May observe on the floor practices for gowning, disinfection and aseptic technique in manufacturing areas, and observe media fills.监控生产领域净化服、消毒和无菌技术,观察培养基灌装
Requirement:
? BA/BS degree in life science with 2 to 4 years directly related laboratory experience or equivalent edu-cation experience combination.
生命科学领域的本科学历,拥有2-4年直接相关的实验室工作经验或同等教育工作经历
? Intermediate knowledge of microbiology methods and instruments, as apply to aseptic pro-cessing. Including validation experience. 一定的应用于无菌工艺的微生物方法和设备知识,包括验证经验
? Intermediate knowledge of GMPs, safety regulations and data integrity
一定的GMP、安全规章和数据完整性知识
? Perform growth promotion testing, and microbiological identification.进行生长促进测试和微生物鉴定
? Assist in performing sterility and bioburden testing, as needed必要时协助进行无菌和生物负荷测试
? Issue excursion notices and assist in investigating root causes.发布异常情况报告,协助进行原因调查
? Responsible for the preparation and updating of SOPs governing the environmental monitoring, utility testing, growth promotion testing and identification methods.负责环境监测、生长促进测试和鉴定方法相关的SOP的起草和更新
? Train other analysts in job functions and assays, as needed.必要时对其他检验员的进行岗位技术培训
? Train manufacturing operators in environment monitoring sampling, as needed.必要时对生产操作员进行环境监测抽样的培训
? Collect trend data and author trend reports.收集趋势数据并发布
? Review EM and Utility monitoring documentation as a peer reviewer.审核环境监测文件
? Execute EM and Utility Method validations.执行EM验证
? May observe on the floor practices for gowning, disinfection and aseptic technique in manufacturing areas, and observe media fills.监控生产领域净化服、消毒和无菌技术,观察培养基灌装
Requirement:
? BA/BS degree in life science with 2 to 4 years directly related laboratory experience or equivalent edu-cation experience combination.
生命科学领域的本科学历,拥有2-4年直接相关的实验室工作经验或同等教育工作经历
? Intermediate knowledge of microbiology methods and instruments, as apply to aseptic pro-cessing. Including validation experience. 一定的应用于无菌工艺的微生物方法和设备知识,包括验证经验
? Intermediate knowledge of GMPs, safety regulations and data integrity
一定的GMP、安全规章和数据完整性知识
公司介绍
浙江天元生物药业有限公司 诚聘
联系方式
- 公司地址:杭州市余杭经济开发区天荷路56号 (邮编:311100)