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Job ID 220857BR Position Title Global Quality Auditor Division Novartis Technical Operations Business Unit NTO QUALITY Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Quality Job Type Full Time Employment Type Regular Job Description Conduct GMP and Quality System audits at Sandoz own sites/entities (e.g. Production sites, commercial affiliates and development entities) and Key Third Party contractors or suppliers as lead or supportive auditor, to monitor that all aspects of the operational business comply with GxP legal and regulatory requirements and the Novartis Group Quality Manual and Policies. In addition, support pharmacovigilance and GCP audits.
•Conduct all necessary assigned audits
•Approve Corrective and Preventive Actions which are necessary due to audit findings; Maintain audit data in Adaptable Quality Workflow Application (incl. reports and follow-up of audits)
•Support training sessions, audit planning and Risk Assessments (e.g. for Supplier Qualification)
•Assist in ensuring that Sandoz sites are prepared for Regulatory Agency Inspections through normal audit activities, “Mock Inspections”, training and other support activities
•Identify and Report Critical and Major Quality and Compliance Risks and Gaps during audit activities using Escalation process as defined •Assist sites in ensuring that Sandoz facilities achieve, maintain and improve the required level of Quality and Compliance through review and determination of quality and compliance deficiencies and providing independent advice, recommendations and solutions during audits
•Ensure effective verification audits of sites with significant quality and compliance issues
•Conduct Pre-Qualification audits of potentially new Suppliers and Contractors
•Conduct effective “For cause” (Directed) audits to investigate frequent e.g. Field Alerts, Recalls, Rejects and Complaints
•Provide effective support during Regulatory Inspections as requested by QA Operations/sites
•Provide “expert” advice and support to project teams for new business/products, to ensure the approach and direction of the CAPA plan and general quality improvements required are focused in the direction of the business strategy and on achieving a successful regulatory outcome •Provide “specialist” advice in area of expertise, both internally within the team and in response to external requests
•Support departmental and cross-regional projects within Global A & C to improve business processes and/or enhance team development Minimum requirements Graduate in Pharmacy, Chemistry, Microbiology, Biochemistry or another related science; additional knowledge in Quality Assurance/Compliance and Auditing.
English fluent in speaking and writing, 2nd language desirable.
min. 8 years of experience in the pharmaceutical or biopharmaceutical industry, e.g. in Pharma Production, Quality Assurance, Quality Control, Development.
Prior Auditing experience desirable.
Practical operational experience.
Good Knowledge of Regulatory Agency Inspection requirements;
Strong Analytical skills.
Very good communication and organizational Skills.
Willing to travel.