GCP Quality Assurance (QA) Specialist

Key Activities and Responsibilities

  • Ensures that the assigned quality systems are compliant with Good clinical practice (GCP) and suitable per company needs (vendor management, training system or other as assigned)
  • Collaborates on supervising GCP compliance and GCP non-compliance resolution across departments
  • Prepares, reviews, and approves quality-related documents
  • Provides QA review and approval for assigned clinical development area documents
  • Monitors performance and compliance of assigned quality systems
  • Performs quality controls (QCs) and internal audits
  • Provides user support and training for assigned quality systems
  • Cooperates with other functions of the company in quality related areas
  • Collaborates on the preparation of business requirements of the computerized systems used by QA

Competences, Skills and Qualification

  • Bachelor or master’s degree (scientific or health-related field preferred, but not a condition)
  • Minimum 1+yrs experience in QA or 3+yrs adequate experience in clinical trials including collaboration with QA
  • Knowledge of QA systems in GCP area required
  • Experience with controlled documentation preparation required
  • Advanced knowledge of English required
  • Knowledge of/experience with the following is of advantage:
    • o risk management tools
    • o QCs and internal audits
    • o Trial Master File
    • o validation principles of computerized systems
    • o Veeva Quality Docs, QMS and eTMF
  • Team player with excellent communication skills
  • Autonomous, proactive, consistent person with good organizational skills

Position is based in Prague

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