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Global GMP Quality Assurance Specialist

vor 2 Monaten

Kundl, Tirol, Österreich Novartis Vollzeit

Sandoz, a global leader in the pharmaceutical industry, is undergoing a transformative period as it continues to innovate and expand its portfolio of sustainable generic and biosimilar medicines.

As a newly listed company, Sandoz is focused on increasing its strategic presence, operating with greater agility, and enhancing shareholder returns. This exciting time in our history presents a unique opportunity for growth and development, both professionally and personally.

Your Key Responsibilities:

As a Global GMP Quality Assurance Specialist, you will play a critical role in supporting the development of an effective global risk-based audit strategy and program. Your key responsibilities will include:

  • Supporting the strategic development of an effective global risk-based audit strategy and program, collecting and incorporating input from various stakeholders.
  • Planning, leading, conducting, documenting, and following up on GMP audits in accordance with Sandoz quality procedures and applicable regulations, standards, and guidance documents.
  • Conducting complex and high-risk audits, such as sterile API, aseptic DP, and combination products, and providing technical guidance and mentoring on audit activities.
  • Preparing audit reports according to Sandoz requirements and timelines, and ensuring appropriate escalation to responsible management in case of critical findings.
  • Assessing the adequacy of responses to audit findings in cooperation with the stakeholder QA representative and auditee.
  • Acting as a GMP compliance consultant for GMP trainings, task forces, and continuous improvement projects, and ensuring the permanent transfer of best practices into the Sandoz QMS system.
  • Reviewing and advising on relevant policies and procedures, and maintaining current knowledge of regulations, standards, and guidance documents.
  • Identifying and reporting best practices and lessons learned to support the development and training of GMP auditors.