微生物实验室分析员 Micro-lab Analyst
迈柯唯医疗设备(苏州)有限公司
- 公司规模:50-150人
- 公司性质:外资(欧美)
- 公司行业:医疗/护理/卫生
职位信息
- 发布日期:2012-08-20
- 工作地点:苏州
- 招聘人数:1
- 工作经验:三年以上
- 学历要求:大专
- 语言要求:英语良好
- 职位类别:生物工程/生物制药 化工实验室研究员/技术员
职位描述
主要工作职责Main Responsibilities
◆ 执行成品, 中间体,原材料,稳定性样品的接收和检测,如初始污染菌检测,无菌测试,热原测试,微粒测试等
Perform microbiological testing on raw materials, finished products, in-process samples and stability samples. Perform bio-burden test, sterility test, pyrogen test, particulate matter counting, etc.
◆ 执行实验室所有设备的验证检测,日常运作监测和维护
Execute the testing activities for lab equipment qualification/ validation, routine monitoring and maintenance.
◆ 熟悉工厂设施和洁净室环境的相关质量要求以求最佳的运行水平, 执行生产洁净室环境和关键设施(如压缩空气,水系统等)验证和日常监测活动
Be knowledgeable about the plant equipment and environment for optimum performance in equipment and environmental cleaning. Carry out the validation and routine monitoring for environment and critical systems (air system, water system, etc.)
◆ 检测培养基和相关试剂的准备
Prepare media and reagents.
◆ 严格遵循法规和公司政策、实验室操作程序的要求(如良好实验室操作规范和良好文件规范),任何不符合的情况发生,需要及时报告
Execute all duties faithfully and responsibly in accordance to compliance requirements, corporate policies and written procedures(GLP, good document practice etc) and to immediately report all observations of GMP non-conformances.
◆ 保持实验室的整洁
Maintain good housekeeping of the laboratory at all times.
◆ 执行安全操作和维持良好的安全的工作环境
Maintain and ensure safe working conditions.
◆ 及时向微生物师汇报日常工作中异常状况,在发生偏差时作为实验室人员配合完成调查处理
Immediately report to Microbiologist all observations of GMP non-conformances during the routine monitoring, assist in exception and nonconformity investigation/ handling.
◆ 完成上级指派的其他工作任务
Accomplish other duties as assigned.
资历Qualification
教育Education
大专毕业、优先考虑微生物,生化,制药或食品等理工科专业
College degree, prefer majored in science of Microbiology, Biochemistry, pharmaceutical, food etc.
工作经历 Woke Experience
◆ 至少3年以上的微生物实验室经历, 有3年以上欧美企业工作经验优先
Minimum of 3 years working experience in microbiological laboratory, above 3 years in EU/US company is preferred.
◆ 有食品,奶制品或制药行业工作经验优先
Food, dairy or pharmaceutical experience is preferred.
◆ 在医疗行业GMP环境下2年工作经验优先
At least 2 years working experience in GMP environment of medical industry is preferred.
语言Language
◆ 能进行简单地英语会话
Simple English conversation.
◆ 较好的英语阅读和理解能力
Good English communication both in reading and understanding.
技能Skill
◆ 熟悉ISO9001, GMP, GLP和验证操作
Familiar with ISO9001, GMP, GLP and validation.
◆ 熟悉微生物实验室的质量控制流程
Be familiar with micro lab internal quality controls.
◆ 良好的办公室软件应用水平
Good computer and software skills.
态度Attitude
◆ 细心谨慎,责任心强
Discretion, strong commitment.
◆ 优秀的团队合作者,沟通者和协调者
Team work spirit. Good communication& coordination skills.
◆ 善于自我激励,积极主动,抗压力强
Self-motivated, initiative and able to work under pressure.
◆ 执行成品, 中间体,原材料,稳定性样品的接收和检测,如初始污染菌检测,无菌测试,热原测试,微粒测试等
Perform microbiological testing on raw materials, finished products, in-process samples and stability samples. Perform bio-burden test, sterility test, pyrogen test, particulate matter counting, etc.
◆ 执行实验室所有设备的验证检测,日常运作监测和维护
Execute the testing activities for lab equipment qualification/ validation, routine monitoring and maintenance.
◆ 熟悉工厂设施和洁净室环境的相关质量要求以求最佳的运行水平, 执行生产洁净室环境和关键设施(如压缩空气,水系统等)验证和日常监测活动
Be knowledgeable about the plant equipment and environment for optimum performance in equipment and environmental cleaning. Carry out the validation and routine monitoring for environment and critical systems (air system, water system, etc.)
◆ 检测培养基和相关试剂的准备
Prepare media and reagents.
◆ 严格遵循法规和公司政策、实验室操作程序的要求(如良好实验室操作规范和良好文件规范),任何不符合的情况发生,需要及时报告
Execute all duties faithfully and responsibly in accordance to compliance requirements, corporate policies and written procedures(GLP, good document practice etc) and to immediately report all observations of GMP non-conformances.
◆ 保持实验室的整洁
Maintain good housekeeping of the laboratory at all times.
◆ 执行安全操作和维持良好的安全的工作环境
Maintain and ensure safe working conditions.
◆ 及时向微生物师汇报日常工作中异常状况,在发生偏差时作为实验室人员配合完成调查处理
Immediately report to Microbiologist all observations of GMP non-conformances during the routine monitoring, assist in exception and nonconformity investigation/ handling.
◆ 完成上级指派的其他工作任务
Accomplish other duties as assigned.
资历Qualification
教育Education
大专毕业、优先考虑微生物,生化,制药或食品等理工科专业
College degree, prefer majored in science of Microbiology, Biochemistry, pharmaceutical, food etc.
工作经历 Woke Experience
◆ 至少3年以上的微生物实验室经历, 有3年以上欧美企业工作经验优先
Minimum of 3 years working experience in microbiological laboratory, above 3 years in EU/US company is preferred.
◆ 有食品,奶制品或制药行业工作经验优先
Food, dairy or pharmaceutical experience is preferred.
◆ 在医疗行业GMP环境下2年工作经验优先
At least 2 years working experience in GMP environment of medical industry is preferred.
语言Language
◆ 能进行简单地英语会话
Simple English conversation.
◆ 较好的英语阅读和理解能力
Good English communication both in reading and understanding.
技能Skill
◆ 熟悉ISO9001, GMP, GLP和验证操作
Familiar with ISO9001, GMP, GLP and validation.
◆ 熟悉微生物实验室的质量控制流程
Be familiar with micro lab internal quality controls.
◆ 良好的办公室软件应用水平
Good computer and software skills.
态度Attitude
◆ 细心谨慎,责任心强
Discretion, strong commitment.
◆ 优秀的团队合作者,沟通者和协调者
Team work spirit. Good communication& coordination skills.
◆ 善于自我激励,积极主动,抗压力强
Self-motivated, initiative and able to work under pressure.
公司介绍
MAQUET is a world famous medical treatment equipments and ,system engineering company with more than 170 years history, which headquartered in Germany. It belongs to the publicly-listed Swedish group of companies Getinge AB and has under it three specialty divisions for Surgical Workplaces, Critical Care, Cardiopulmonary. As a global market leader and one of largest suppliers of Emergency Rooms, Operating Rooms and Intensive Care Units, MAQUET is always devoting to perfect the quality, efficiency of medical treatment and workflow-optimized clinical infrastructure for providing worldwide hospitals with best quality system engineering and line products. The MAQUET organization is to be found all over the world, with 36 direct subsidiaries on all the continents and with over 200 specialist distributors and partner companies in sales and service representing MAQUET.
MAQUET (Suzhou) Co., Ltd was established in April of 2007. As the only production bases outside Europe, MAQUET (Suzhou) upholds the concept of quality enhancement and high efficiency all the time. Benefiting form the successful experience of operations in German and French factory, we supply the global market with series of best-quality products.
We attach great importance to the employees self growth and development, valuing the diversity of individuals, ideas and what they bring to the workplace. At MAQUET, with favourable working and personal development environment, we offer all of the employees with large range of career opportunity and better training (domestic or overseas training) opportunities.
The dynamic development of MAQUET and the multiplicity of our fields of business offer many career challenges. To further strengthen our team, we are looking for co-workers dedicated to enhancing our success. You are warmly welcomed to join us!
总部位于德国的MAQUET 是一家拥有170多年悠久历史的医疗设备和系统工程公司,隶属瑞典GETINGE AB集团。集团下设外科系统部、心脏外科部、重症护理部,所辖品牌均为行业领导者。作为全球手术室﹑ICU医疗工程和设备最大供应商之一,MAQUET一直致力于完善医学治疗的质量、效果和工作流程,为全球医院的手术室、心胸外科、ICU提供最具品质的系统工程和系列产品。至今,MAQUET在全球已设有三十六个直属销售机构 ,超过两百个分销商和服务机构。
迈柯唯医疗设备(苏州)有限公司于2007年4月正式成立。作为集团外科系统部在欧洲本土以外的唯一的生产基地,迈柯唯苏州始终坚持高品质、高效率的制造理念,同时借鉴公司德国和法国工厂的丰富经验,向全球市场提供顶尖的医疗设备产品。
公司注重员工的成长及培养,珍惜每个雇员的多样性、观点以及他们为公司所创造的价值。公司拥有良好的工作和个人发展环境,并提供广阔的职业生涯和优良的国内/国外培训机会。
MAQUET (Suzhou) Co., Ltd was established in April of 2007. As the only production bases outside Europe, MAQUET (Suzhou) upholds the concept of quality enhancement and high efficiency all the time. Benefiting form the successful experience of operations in German and French factory, we supply the global market with series of best-quality products.
We attach great importance to the employees self growth and development, valuing the diversity of individuals, ideas and what they bring to the workplace. At MAQUET, with favourable working and personal development environment, we offer all of the employees with large range of career opportunity and better training (domestic or overseas training) opportunities.
The dynamic development of MAQUET and the multiplicity of our fields of business offer many career challenges. To further strengthen our team, we are looking for co-workers dedicated to enhancing our success. You are warmly welcomed to join us!
总部位于德国的MAQUET 是一家拥有170多年悠久历史的医疗设备和系统工程公司,隶属瑞典GETINGE AB集团。集团下设外科系统部、心脏外科部、重症护理部,所辖品牌均为行业领导者。作为全球手术室﹑ICU医疗工程和设备最大供应商之一,MAQUET一直致力于完善医学治疗的质量、效果和工作流程,为全球医院的手术室、心胸外科、ICU提供最具品质的系统工程和系列产品。至今,MAQUET在全球已设有三十六个直属销售机构 ,超过两百个分销商和服务机构。
迈柯唯医疗设备(苏州)有限公司于2007年4月正式成立。作为集团外科系统部在欧洲本土以外的唯一的生产基地,迈柯唯苏州始终坚持高品质、高效率的制造理念,同时借鉴公司德国和法国工厂的丰富经验,向全球市场提供顶尖的医疗设备产品。
公司注重员工的成长及培养,珍惜每个雇员的多样性、观点以及他们为公司所创造的价值。公司拥有良好的工作和个人发展环境,并提供广阔的职业生涯和优良的国内/国外培训机会。