Audit Manager - Pharma 上海

月薪： 2.5-3万/月

该公司所有职位
  • 10年以上经验
  • 本科
  • 招1人
  • 01-03 发布

职位描述

Responsibilities:-Perform Helm’s supplier GMP audits, prepare audit report and CAPA follow up-Accompany authority inspections-Join customer audits if necessary-Support Helm companies on Regulatory affairs-Support Helm companies on Quality Assurance issues, e.g. changes, quality complaints, supplier qualifications, questionnaires, technical agreement, specification-Support Product manager for the new supplier selection if necessary-Support on other technical issues.Territory:Entire ChinaReporting to:Head of Department PharmaSubordinate:NoneLocation:Shanghai. Extensive travel in China neededRequirements:Education-Bachelor degree or above in Pharmaceuticals, Bio-pharmaceuticals, pharmaceutical engineering or Pharmaceutical chemicals; Subject in Pharmaceutical English is a plus.Experience-Minimum 8-10 years work experience in quality assurance, production, GMP audits, regulatory affairs or other relevant operation areas;-Good knowledge of pharmaceutical products, international GMP requirements;-Familiar with the international guidelines, such as ICH, EDQM and US FDA;-Familiar with the regulatory affairs requirements of EU, such as CEP, DMF ;-Experience in multi-national enterprise is a plus.Personal Profile-Self-motivated and responsible;-Good ability of continuous learning;-Problem solving attitude;-Good team player with good communication skill;-Ability to work under pressure;Languages-Fluent Chinese-Excellent English skills, spoken and written, CET-6 or above 职能类别： 药品生产/质量管理

联系方式

南京西路

公司信息

Helm is one the earliest foreign distributors of chemical products with operations in China, with a dedicated team in the country since 1981.Since then, we have steadily developed our activities in China. We have developed sizeable long-term business with nearly 400 suppliers and export more than 350 products including pharmaceutical API, medical devices, nutrition additives, agrochemicals, fertilizer and chemicals.Thanks to our network of five sales offices and a highly motivated team strategically located close to the main markets across China, we distribute chemical products to more than 600 customers, most of which small and medium sized enterprises.With our China head office in Shanghai, our company is organized into seven departments: Pharmaceutical, Nutrition, Crop Protection, Fertilizer, Chemicals, Quality, and Finance & Administration. Our team of highly experienced professionals monitors the Chinese market, leads day-to-day business, and develops new opportunities to serve you - our partners.Contact us to discuss how we can support you in better serving the highly dynamic local market or leveraging the great sourcing opportunities of China.

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