上海招聘

PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB:
Serves as a subject matter expert to provide guidance and expertise, and as a reviewer on account of quality viewpoint in regard to process technology transfer and product/system life cycle initiative. Recognize, develop and implement various essential validation activities based on risk assessment and user’s requirement.

MAIN ACCOUNTABILITIES:
1.Provide quality expertise in the project to compliance to local medical device regulations and relevance codes.
2.Participate and support in development on project plan, quality plan and validation plan activities, and raise
3.Serves as a member as a quality representative and chairperson for project control, and deliverable file review based on GxP and other relevant codes and regulations.
4.Assist cross function on the product and process risk assessment, identification and mitigation in project and along all the product/system life cycle.
5.Management with non-conformities, CAPA, drives root cause analysis on account of specific statically approach or tools.
6.Management with Change Control process, and support requisite re-validation or re-qualification activities through the product/system life cycle.
7.Execute internal/or supervise supplier validation activities in regard to project or validation plan, including supporting supplier or internal audit activities as necessary.
8.Assure quality records and documentations is generated, reviewed and approved in according to QMS procedure, and provide essential risk analysis and validation training to project teams as necessary.

KNOWLEDGE, LANGUAGE AND EXPERIENCE:
-Bachelor’s degree or above, Pharmaceutical science/engineering or related majors. At least 5 years’ experience in IVD, pharmaceutical or cosmetic related scientific field, served as project QA or/and validation engineer.
-Familiar with quality and validation relevant ISO codes, including ISO 13485, ISO 14971, ISO 14644, ISO 17665 etc.
-Knowledge of domestic pharmaceutical or medical device GMP, also be aware of EU or FDA GMP is as better.
-Good English oral and technical written ability, no communication barriers with US team.
-Familiar with CFR 21 Part 11 and GAMP is as better.
-Familiar with Lean and six sigma methodology is as better.

生物梅里埃公司创建于1963年，公司依赖自身的科技研究和工业生产资源，始终致力于开发作为医疗和工业用途的体外诊断产品。 集团专门设计、开发、生产和推广应用在临床和工业的系统。生物梅里埃的诊断系统是由试剂、仪器和软件组成，主要是为传染病、工业微生物控制、心血管病和肿瘤病等四个主要策略性领域来设计。
 
在2009年，公司销售额为12亿2千3百万欧元，集团共有17个生产基地和13个研究中心，分布于欧洲、北美洲和南美洲。集团全球拥有39个分公司，至2009年12月31日集团员工超过6,500人。
 
生物梅里埃公司产品有两个应用领域 : 临床和工业，临床市场占总销售额的85%，而工业市场占15%。工业的应用主要在食品、药品和化妆品的微生物分析，增长非常迅速，生物梅里埃是全球体外诊断领域的第八大生产商。

 
生物梅里埃中国有限公司已经20年的发展，自动化微生物鉴定分析系统的用户已达1400余家，自动微生物培养系统已达700余家，全自动细菌计数系统60 余台，手工产品用户覆盖全国的省市70%以上。同时公司拥有数十名微生物临床及工业领域专业人员和工程技术人员，其中许多人员都来自检验一线，拥有丰富的检验经验和仪器维修经验。全面负责生物梅里埃公司产品的销售，仪器的安装、维护及保养，以及用户的培训及技术支持。
 
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