Quality Assurance Specialist

vor 1 Woche

Kundl, Tirol, Österreich TECCON Consulting GmbH Vollzeit € 60.000 - € 120.000 pro Jahr

Vollzeit | Kundl

Are you an expert in your field, ready to apply your know-how to exciting projects?
Join the Hamburger TECCON Group, a team of over 450 professionals specializing in IT, engineering, and business. We develop innovative solutions for prestigious clients, aiming to discover and nurture human potential by creating tailored connections between companies and talents. Bring your expertise to our projects and actively shape the future.

Deine Aufgaben

  • Third-Party Quality Oversight: Take ownership of QA responsibilities for third-party and vendor activities – from onboarding to full lifecycle management – ensuring compliance with global GxP and TRD quality standards.
  • Process Improvement & Integration: Drive global initiatives in Third-Party Management, including quality risk assessments, process optimization projects, and seamless integration of new vendors from BD&L activities.
  • Compliance & Audit Readiness: Evaluate and monitor third-party compliance status, track assessments and due dates, and ensure adherence to all regulatory and Novartis QA requirements.
  • Quality Agreements: Lead the drafting, negotiation, and finalization of Quality Agreements in close collaboration with technical and QA teams, aligned with SOPs and Health Authority expectations.
  • SOP Management: Develop, update, and standardize SOPs, templates, and related QA documentation to ensure global consistency and compliance in Third-Party Quality Management.
  • Risk & Performance Monitoring: Conduct risk assessments, analyze vendor performance metrics, identify trends early, and initiate corrective actions or escalations when needed.

Dein Profil

  • Education & Experience: Master's degree in Life Sciences or related field, or Bachelor's degree/Technician with at least 5 years of experience in a GxP-regulated pharmaceutical environment.
  • GxP & QA Expertise: Strong knowledge of cGMP principles and proven experience in Technical Development, Production, or Quality Assurance.
  • Regulatory & Technical Insight: Solid understanding of scientific, technical, and regulatory requirements in pharmaceutical development and manufacturing.
  • Analytical & Decision-Making Skills: Demonstrated ability to evaluate cGMP compliance, analyze complex data, and make sound quality decisions.
  • Organizational Agility: Structured, proactive, and able to manage multiple priorities and stakeholders in a dynamic global environment.
  • Communication & Collaboration: Clear communicator with strong interpersonal skills and a collaborative mindset to work effectively across internal teams and external partners.

Deine Benefits

  • Exciting, self-organized and responsible tasks
  • Long-term employment relationship, pleasant working atmosphere in a young, dedicated team
  • Flexi time agreement, flexible working time model, work-life balance
  • Opportunities for specialization and subject-specific further education and training
  • Extremely collegial team with a friendly approach
  • Various development opportunities within the TECCON Group

The gross annual salary is at least EUR but of course we offer overpayment in line with the market, depending on qualifications and professional experience.

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