How would you like to be a key part of the Global Auditing at Novartis, building upon and maintaining our exceptional standards?
We pursue amazing talent across Spain!
This position comes with a flexible location and we are ready to hire this role in the city of preference (within Spain) of the successful candidate.
In this role you will lead, support and report independent GMP audits according to the Novartis 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.
The Global GMP Senior Quality Auditor also ensures alignment with the strategic direction of the company and assists in driving implementation of the applicable actions and provides consultation to Novartis business units through risk-based assessments.
Act as SME for assigned areas of responsibility.
About the Role In this role you will be required to travel up to 60% of the time.
Major Accountabilities: 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 Novartis Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents.
Provide technical guidance, mentoring, and training on audit activities.
Prepare audit reports according to NVS requirements and timelines.
Identify and report best practices and lessons learned to support development/training of GMP auditors.
Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to NVS 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.
Maintain current knowledge of regulations, standards, and guidance documents.
Minimum Requirements: At least 12 years broad experience in Pharmaceutical or Medical Device Industry.
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