Nvs Compliance Quality Rlt Support (Fixed Term)

NVS Compliance Quality RLT support (fixed term)Job ID: REQ-10016965
Aug 05, 2024
Location: Italy
SummaryAssurance that the product quality conforms with specifications and that production activity is compliant with Novartis quality policy and GxP requirements. Ensure that relevant documentation is up-to-date and archived correctly. Ensure "state of the art" GxP know-how and future trends in the field of GxP.
About the RoleMajor accountabilities: Ensure compliance with the Novartis Quality Manual and relevant GxP regulatory requirements.Prepare, review, and check batch documentation for correctness and completeness.Conduct self-inspection schemes for all sections.Monitor actions and corrections accordingly.Conduct GxP monitoring and QA investigations for noncompliance.Archive documentation and manage critical quality issues.Ensure timely execution of required actions.Escalate issues per the Novartis escalation policy.Lead Global Quality Assessments and manage filing.Assess quality trends and drive continuous improvement.Identify areas requiring SOPs and initiate their introduction.Plan and monitor GxP training for all employees.Maintain cross-functional contacts and follow up on quality developments.Ensure compliance with drug product specifications and regulations.Report technical complaints/adverse events within 24 hours.Key performance indicators: Local GMP/GDP Quality System in place and updated.Proactive identification and mitigation of GMP/GDP risks.Effective Operations Management and Execution.Skills: Change ControlDealing With AmbiguityGuideline ComplianceProduct ReleaseQuality AssuranceQuality ManagementRegulatory KnowledgeTechnological ExpertiseWhy Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients' lives.
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Division: Operations
Business Unit: Innovative Medicines
Location: Italy
Site: Milano
Company / Legal Entity: IT08 (FCRS = IT008) Novartis Farma S.p.A.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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