Summary Our global Quality audit team is hiring! At Sandoz, our goal is not just to increase access, but to do so in a sustainable and responsible way: finding the right balance between guaranteed quality, reliable supply and appropriate pricing. Our aim is to excel at all three, ensuring we never compromise on quality.

As GMP Senior Auditor you'll lead, support and report independent GMP audits according to the Sandoz Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. The audits performed include internal and external targets of manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers.

Support the strategic development of an effective general 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. Provide technical guidance, mentoring, and training on audit activities. 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. 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 Mentor junior GMP staff as required. Identify and report best practices and lessons learned to support development/training of GMP auditors. Excellent oral and written English communication skills.

German, French, Italian, Chinese, or Spanish) is valued. ~ At least 10 years broad experience in Pharmaceutical or Medical Device Industry. ~ The operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority. ~3 years auditing experience preferred, and excellent knowledge of regulatory requirements. ~ DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems. ~ Experience and/or interaction with local Health Authority and sporadically with other Health Authorities. ~

📌 Global Senior GMP Auditor (Madrid)
🏢 Sandoz
📍 Madrid