上海招聘

1. Implementing pharma & medical device regulatory compliance services including but not limited to regulatory (such as cGMP) training, consulting, gap analysis, mock inspection, CAPA consulting, and/or regulatory filing (such as DMF/CEP/510K/ANDA) with FDA/ EDQM/ NMPA/ WHO/ PMDA/ TGA and other authorities or organisations; 实施药品医疗器械合规服务，包括但不限于：cGMP培训、咨询、差距分析、模拟检查、整改咨询，和/或向FDA/ EDQM/ NMPA/ WHO/ PMDA/ TGA等监管机构或组织提交注册申请，例如DMF、CEP、510K、ANDA等。

2. Assisting in developing the above services including but not limited to prepare or update slides based on experience and current regulations/guidance, write articles on regulatory hotspots, make speeches at seminars, reply to questions from sales/marketing colleagues. 协助开发上述服务，包括但不限于：基于经验与现行监管技术要求编制或更新幻灯片，就监管热点写文章，在研讨会上演讲，回复销售和市场部同事的问询。

3. Participate other LESS projects that allocated by management. 参与领导安排的LESS其他项目。

职位要求：

1. Bachelors degree or above, major in pharmaceutical or chemical or biochemistry other related area; 本科及以上，药学、化学、生化或相关专业；

2. Over 7 years of experience in pharmaceutical/medical device industry; 7年以上药品医疗器械行业经验；

3. Over 3 years of direct experience in dealing with customer GMP audits and regulatory inspections; 3年以上直接应对客户审计与官方检查经验；

4. Over 3 years of direct and operation experience in regulatory registration with FDA/ EDQM/ NMPA/ WHO/ PMDA/ TGA and/or other stringent organisations/authorities; 3年以上国内外注册***手直接经验；

5. Have good knowledge of cGMP and quality system with direct experience in at least two sub-systems of cGMP , and/or ICH-quality guidelines; 熟悉药品医疗器械质量体系和cGMP要求，有至少2个cGMP分体系的直接经验；和/或熟悉ICH质量指南；

6. Excellent communication and interpersonal skill; 优秀的沟通与人际交往能力；

7. Good command of written and oral English and Chinese; other language (such as Japanese or Portuguese) is a plus; 中英文听说读写熟练；会其他语种(例如日语或葡语)可加分；

8. Strong individual contributor as well as a team player; 能独当一面工作，也能与团队成员良好合作；

9. Integrity and high self-discipline. 诚信，自律。

上海公开招聘日正在进行中！
时间及地址：
3月19日 13：30-17：00 徐汇区宜山路889号4号楼2楼 灵感与创造会议室/独立会议室
3月19日 9：00-17：30 上海市浦东新区桂桥路1201号T52-8
3月20日 9：00-17：30 徐汇区宜山路801号B栋4楼会议室

Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and over 40,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains.
源自1885年爱迪生实验室，Intertek(天祥)集团是全球领先的质量和安全服务机构。从审核、检验，到测试、质量保证和认证，Intertek致力为客户的产品和流程增加价值，促进客户在全球市场取得成功。Intertek在超过100个国家拥有1,000多家实验室和分支机构，以及超过40,000名员工，凭借专业技术、资源和全球网络，为客户提供优质服务。Intertek集团(LSE: ITRK)在伦敦证券交易所上市，是英国富时100指数成份股之一。Intertek的客户包括众多的国际知名品牌、跨国公司、本地企业以及政府机构。
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