Global Quality Auditor (NTO CIMA)

Job description

Job Description

Plan and perform audits according to the requirements specified in the respective Novartis Quality Module. Audits include: pre-qualification audits, routine GMP surveillance audits (both System Based audits and audit focused on special areas/functions e.g. on Stability Program), for cause audits, mock inspections at suppliers/ contractors. Conduct pre-approval/pre-submission project reviews and “mock” pre-approval inspections at contractors/ suppliers level. Provide regulatory guidance for timely remediation and recommendations regarding accepta-bility of the proposed filing. Prepare audit reports according to NVS requirements and timelines. 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. Ensure adequate definition, recording of mitigation plan when applicable. Assess the adequacy of responses (CAPA plans) to audit findings in co-operation with Follow-up Responsible Person (FURP) and Auditee (Quality Responsible Person, QARP). Act as GMP compliance consultant for GMP trainings, task forces, con-tinuous improvement projects etc. Review and revise relevant procedures, as needed, support compliances activities as needed. Maintain current knowledge of regulations and elaborate best practices auditing guideline (when applicable). Support development/training of GMP auditors. Support HA commitments and global commitments/initiatives as an outcome of inspection findings

Desired profile

Minimum requirements

Graduate degree in Chemistry, Pharmacy, Microbiology, Engineering or another related science Excellent oral and written English communication skills. Preferable: Good knowledge/mother tongue of an additional language (e.g. German, French, Italian, Chinese, Japanese, Spanish) At least 10 years broad experience in Pharmaceutical Industry. The operational experience should in-clude QA/QC management and manu-facturing, or development or other rele-vant experience e.g. working at a regula-tory health authority. At least 3 years auditing experience, including preferably auditor certification by an industry recognized body e.g. ASQ and excellent knowledge of regulatory re-quirements. Willingness to travel approx. 60% of the time Expertise in at latest, one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems. Experience and/ or interaction with lo-cal Health Authority and sporadically with other Health Authorities. Strong interpersonal skills, including di-plomacy and persuasion, used in ob-taining cooperation and consensus with Novartis colleagues, vendors and custom-ers. Sound and practical judgment in the interp