Octapharma

Quality Auditor – Regulatory Compliance Specialist

Octapharma

full-time

Posted on:

Location Type: Office

Location: Wien • Austria

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 €4,270 per month

About the role

  • Ensure quality and regulatory compliance of plasma suppliers at a global level
  • Manage change control, deviations, and quality-related contracts
  • Conduct external supplier audits and participate in customer and internal audits at our facility
  • Analyze and trend supplier-related quality data
  • Create, review, and provide training 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 and second-level checks in a regulatory database
  • Ensure compliance with EU and EMA Plasma Master File (PMF) requirements
  • Prepare regulatory documentation for annual PMF submissions; 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 teams

Requirements

  • Degree in Life Sciences (e.g., Biology, Chemistry, or Pharmaceutical Sciences)
  • Professional experience in Quality Assurance within the pharmaceutical industry
  • Proficient knowledge of GMP, EU and FDA guidelines
  • Experience with quality management systems, particularly Veeva
  • Auditor certification and audit experience; completion of a basic quality auditor or ISO course is a strong advantage
  • Structured, reliable, and independent working style, combined with strong communication skills
  • Ability to manage priorities, meet deadlines, and demonstrate excellent organizational skills
  • Fluency in English and German is required
  • Willingness to travel internationally (up to 40%)
  • Valid driver’s license
Benefits
  • Company restaurant & meal subsidy
  • Training and further education
  • Health promotion and wellness programs
  • Parking spaces and good public transport connections
  • Company and team events
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality assuranceGMPEU guidelinesFDA guidelinesquality management systemsdata analysisregulatory complianceSOP creationauditingregulatory documentation
Soft Skills
strong communication skillsorganizational skillsability to manage prioritiesreliable working styleindependent working style
Certifications
auditor certificationISO course completion