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Global GMP Senior Quality Auditor

Novartis · Barcelona, Catalonia, ES

Band Level 5 Job Description Summary In this role you will lead, support and report independent GMP audits according to the Novartis Quality System and the c...

Job description

Band Level 5 Job Description Summary: 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 strategic direction of the company and assist in driving implementation of the applicable actions and provides consultation to Novartis business units through risk based assessments. Job Description: In this role you will be required to travel up to 60% of 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 N...