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Octapharma

Quality Auditor & Regulatory Compliance Specialist (m/f/d) - Group Quality Plasma

Octapharma
ViennaEUR4K+ / monthPosted 1 months ago
Full-timeonsitemid

Job Description

  • Ensure quality and regulatory compliance of plasma suppliers on a global level
  • Manage change control, deviations, and quality-related contracts
  • Conduct external supplier audits, participation in customer/internal audits at our facility
  • Analyze and trend supplier-related quality data
  • Create, review, and train on SOPs and related procedures
  • Qualify plasma suppliers and service providers (e.g. testing laboratories, logistics partners) 
  • Monitor and ensure continuous supplier compliance throughout the lifecycle of supply agreements
  • Maintain and annually update plasma supplier data 
  • Perform data entry, second-level checks in a Regulatory Database
  • Ensure compliance with EU and EMA Plasma Master File (PMF) requirements
  • Prepare regulatory documentation for annual PMF submission; evaluate epidemiological data, trends, and risks
  • Prepare regulatory responses for marketing authorizations and PMF approvals
  • Collaborate with internal and external stakeholders, including suppliers, health authorities, and cross-functional departments

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    About Octapharma
    1001-5000 employees
    Lachen, Switzerland, CH
    Website
    Quality Auditor & Regulatory Compliance Specialist (m/f/d) - Group Quality Plasma at Octapharma | Renata