SummaryIn 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 Integral 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.Support the strategic development of an effective global risk-based audit strategy and program.

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.Identify and report best practices and lessons learned to support development/training of GMP auditors.



Mentor junior GMP staff as required .Act as GMP compliance consultant for GMP trainings, task forces, continuous improvement projects as needed.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.12+ years broad experience in Pharmaceutical or Medical Device Industry.

Solid operational experience, that should include QA/QC management and manufacturing, development or other relevant experience e.g. working at a regulatory health authority.DP Manufacturing, Laboratories activities, Medical Devices, API, Biologics, Microbiology, Computer System Validation, Quality Systems, Cell&Gene; therapy, Radioligand therapy.Fluent English, written and spoken.

Experience and/or interaction with local Health Authority and sporadically with other Health Authorities is a plus.Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world.

LjubljanaType: Full time

📌 Junior Quality Control Analyst (Cataluña)
🏢 Novartis
📍 Cataluña