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 that all aspects of the handling, manufacturing and distribution of biopharmaceutical/pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement, and meet relevant GxP regulatory requirements.Prepare, review, and check the batch documentation for correctness and completeness, and safely archive the original documents for the prescribed period.Plan, conduct, and monitor self-inspection schemes for all sections.Monitor actions and corrections accordingly.Conduct GxP monitoring on all sections, conduct QA investigations for noncompliance, and follow up on corrective actions.Archive relative documentation and manage/approve critical quality issues (deviations, complaints, recalls, counterfeits, product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual.Ensure investigations are correctly executed and all required actions are taken appropriately and in a timely fashion.Escalate any issues or instances of instability per the Novartis escalation policy and initiate any market actions that are required.Decide on escalation to Senior Management Level and lead Global Quality Assessments, managing filing accordingly.Ensure that Change requests are managed according to the Novartis SOPs from receipt through to implementation and closure.Assess quality trends and drive continuous improvement for processes and product quality performance.Maintain access to regulatory and Pharmaceutical authorities in respect to up-to-date GxP knowledge.Identify repetitive activities and regulatory areas for which SOPs are required and initiate their introduction.Plan, initiate, and monitor basic GxP training for all employees at regular intervals.Be responsible for the annual training program and its implementation.Establish and maintain cross-functional contacts with peer organizations and authorities and follow up on quality-related developments in the field of Pharmaceutical products.Support launches of products in close collaboration with BD and L partners and/or development organizations.Ensure that all drug products are released to the market in accordance with registered specifications and local/international regulations.Maintain coordinated contact with all parties (Regulatory Authorities, local partners, stakeholders, and Global QA).Report technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.Distribute marketing samples where applicable.Key performance indicators: Local GMP/GDP Quality System in place and continuously updated as required.GMP/GDP risks proactively identified and effectively mitigated.Functional breadth and operations management and execution.Skills: Change ControlDealing With AmbiguityGuidelineProduct ReleaseQuality AssuranceQuality ManagementRegulationTechnological ExpertiseLanguages: Why 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. Ready to create a brighter future together? Learn more about our culture. Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: Join now. Division: Operations
Business Unit: Innovative Medicines
Location: Italy
Site: Milano
Company / Legal Entity: IT08 (FCRS = IT008) Novartis Farma S.p.A.
Functional Area: Quality
Job Type: Full time
Employment Type: Regular
Shift Work: No
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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