• 无工作经验
  • 招1人
  • 11-09 发布

职位描述

职位描述: JD:Participate and coordinate on quality management activities and GMP related support for suppliers and headoffice.Supplier Qualification from GMP perspectives including documentation review, on site audits, coordination, CAPA follow up.Provide guidance and training to suppliers on QA system improvements.Go business trip with headoffice technical experts for QA, QC, production and technology support work.Work for registration, coordination, evaluation and follow-up of Changes, Non-conformities on external suppliers and contract manufactures.Identify deficiencies and make plan to assist suppliers to achieve EU GMP compliance.Other activities to support company Quality Management DivisionKnowleage of QA management on ints, API and formulation. RequirementsAt least 3 years of working experience within the pharmaceutical industryGraduation in sciences (e.g. chemist, pharmacist, biologist) or similar educationknowledge on pharmaceutical guidelines (e. g. EU GMP, ICH-Guidelines, Chinese GMP etc.)Willingness to travelFluent level of English, both spoken and written 职能类别: 药品生产/质量管理

联系方式

新金桥路1122号方正大厦

公司信息

斯洛文尼亚KRKA克尔卡新梅斯托制药股份有限公司是欧洲著名的跨国医药公司,年销售额过10亿欧元,在全球30几个国家设有分支机构,在5个国家开立了工厂,员工过9000人。公司于2006年在上海设立了代表处,迄今上海代表处的主要职能是在中国市场的原料采购,产品质量控制监管以及成品药的引进注册等工作。   更详细的公司信息,请访问我们的公司网站:www.krka.biz/en/

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