Global GMP Quality Assurance Specialist

vor 4 Wochen

Kundl, Tirol, Österreich Novartis Vollzeit
Global GMP Quality Auditor

Sandoz is undergoing a transformative period as a global leader in sustainable Generic and Biosimilar medicines.

As an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for Sandoz associates.

This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Your Key Responsibilities:
  • Support the development of an effective global risk-based audit strategy and program.
  • Plan, lead, conduct, document, and follow-up of GMP audits according to Sandoz quality procedures and applicable regulations.
  • Provide technical guidance, mentoring, and training on audit activities and regulatory guidance for timely remediation.
  • Prepare audit reports according to Sandoz requirements and timelines.
  • Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures.
  • Assess the adequacy of responses to audit findings in cooperation with the stakeholder QA representative and auditee.
  • Act as GMP compliance consultant for GMP trainings, task forces, and continuous improvement projects as needed.
  • Review and advise on relevant policies and procedures.
  • Maintain current knowledge of regulations, standards, and guidance documents.
  • Identify and report best practices and lessons learned to support development/training of GMP auditors.

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