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Ergomed1 week ago

Quality Specialist, Deviations & CAPAs

On-site · Zagreb, Zagreb, Croatia

Type
Full Time
Level
Mid Level
Education
Masters Degree
Company size
Large

Job Summary

Quality Specialist负责领导Deviations (Devs) 与 CAPAs 的生命周期管理,确保遵循全球法规与公司要求;协助根本原因分析、对Dev/CAPA的工作流管理、为运营提供质量与合规方面的专业支持;在审核与检查中担任Dev与CAPA主题专家并协助趋势分析与培训相关的程序性指标汇报。

Required Qualifications

  • Prior Pharmacovigilance (GVP) experience is desirable
  • Prior Clinical (GCP) experience is beneficial
  • Prior experience in a Quality and/or Compliance role is required
  • Experience of using an electronic Quality Management System desirable but not required
  • Fluent in English (additional language is a plus)
  • MS Office, particularly advanced skills in Excel and Word
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Ergomed

Quality Specialist, Deviations & CAPAs

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