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Quality Assurance Specialist

The Programme

再鼎医药是一家总部设立于上海张江,致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药,在肿瘤、抗感染、自身免疫等方面建立了全面的产品线,服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。

Responsibilities

  • Support QMS daily work including:
    • SOP management and archive management
    • Coordinate to draft training plan, collect and maintain training material, organize the training, and retain training records and personnel file summary
    • Maintain deviation, change control, and CAPA records and follow up with open cases
    • Support vendor management to maintain the relevant documentation
    • Support internal audit, vendor audit, site audit and regulatory inspection
    • Support other quality related activities or tasks assigned by the leader, e.g., periodic QA summary
  • Support discovery lab to comply with the Good Documentation Practice and basic requirements of Good Laboratory Practice
  • Be a role as SH, SZ, and HK coordinators to support communication and teamwork of product pipeline.

Required Skills and Abilities

  • Bachelor of Science or above in medical or pharmacy or a life/biological science or quality-related field, or equivalent combination of education, training and experience
  • Good communication skill
  • Able to work in a team as well as to work independently
  • Fluent in English
  • Good computer skills including Microsoft office and PDF
Closed a year ago
Closed a year ago
  • Job type:Graduate Jobs
  • Disciplines:

    Pharmaceuticals, Science

  • Citizenships:

  • Locations:

    Shanghai (China)

  • Closing Date:15th May 2019, 6:00 pm

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