Global GMP Quality Auditor (d/f/m), Kundl, Austria

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now 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 us, the 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.

Join us as a Founder of our 'new' Sandoz!

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate and incorporate input into the audit strategy and plan.
• Plan, lead, conduct, document and follow-up of GMP audit according to the requirements specified in the respective Sandoz quality procedures as well as applicable regulations, standards, quality agreements and guidance documents.
• For this role auditors will be given more complex and higher-risk audits, such as sterile API, aseptic DP and combination products. The ability to assess risk of these operations is critical to success.
• Provide technical guidance, mentoring and training on audit activities as well as regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.
• 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 according to Sandoz requirements on management escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable.
• Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and auditee.
• Act as GMP compliance consultant for GMP trainings, task forces, continuous improvement projects as needed. Assure permanent transfer of best practice identified during the audit into Sandoz QMS system.
• 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.