QA Senior Specialist 北京

月薪： 1-1.5万/月

该公司所有职位
  • 3-4年经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： Porpose of the role?To maintain and develop local quality assurance system based on Merck Serono corporate standards and with the local GSP (GDP) regulations.?Supplier and distributors management including audit, qualification, quality technical agreement management etc.Functional tasks?Develop and maintain the local SOPs and Working Instructions based on quality related corporate policies, guidelines, procedures and local GSP requirements?Compliance and qualification management of vendors (suppliers), customers (distributors)- Participate in early age of new supplier/distributor development, e.g. due diligence visit- Be responsible to coordinate team work to sign and maintain Quality and Technical Agreements （QTAs） with all GSP related suppliers/distributors;- Establish annual audit plan for the suppliers/distributors based on risk assessment and business need. Assign qualified auditors for the on-site audit and ensure the CAPAs being managed effectively;- Implement periodic quality review for suppliers/distributors;- Implement risk management on supplier/distributor management.- Implement 3PL on-site monitoring and communication periodically.- Participate in the handling of quality events related to supplier/distributors.- Archive the qualification documents of suppliers/distributors.?Manage internal inspection on quality management system according to global standards and local regulatory requirements including inspection planning, organization, reporting, follow-up actions plan and implementation etc.?Manage the intra-company quality agreements to ensure the effectiveness and applicability?Coordinate the preparation for authority inspections to ensure the sustainable compliance status of GSP company?Key user of SAP to ensure the GSP compliance of computerized system to be used for GSP related businessEducation/Languages?Bachelor degree or above in pharmacy, biology or chemistry?At least 5 years working experiences in QA/QC area of pharmaceutical companies of manufacturing, distribution or trading?Experience of working in QA area in multinational pharmaceutical companies is preferred?Working experience of GMP/GSP auditing is preferred?Licensed pharmacist is preferred?Good English skill at reading, writing, and listeningProfessional/Technical Skills?Good communication skills of both scientific and non-scientific information?Professional knowledge in GSP, GMP and GDP?Practical experience in SAP?Problem solving ability and skill?Ability to self learning 职能类别： 药品生产/质量管理 供应商管理 关键字： QA QC pharmacist GMP GSP SAP suppliers distributors 经销商

联系方式

北京市朝阳区

公司信息

默克雪兰诺有限公司 默克雪兰诺是总部位于德国达姆施塔特的全球医药和化工集团默克公司旗下生物制药业务分支。默克雪兰诺总部设在瑞士日内瓦，致力于发现、开发、生产和销售针对特定适应症的化学和生物的处方药。北美业务在美国和加拿大以EMD 雪兰诺的名称运营。 默克雪兰诺中国总部位于北京，拥有员工约1200人，业务遍及全国。目前，默克雪兰诺在中国经营9个领域18种药品，在未来几年里，还将上市多种新药。

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