Giulia Amanti

Experience

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  Pharmacy

  Oct 2011 - Aug 2012

  Internship
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  Pharmacy

  May 2013 - Feb 2014

  Pharmacist

  Responsabilities:- support in keeping a register of controlled drugs for legal and stock control purposes,- monitoring blood pressure, - ordering, selling and controlling medicines and other stock;- meeting representatives of products (training),- preparing publicity materials and displays, - processing prescriptions and dispensing medications.

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  Novartis Vaccines

  Mar 2014 - Dec 2014

  Supplier Quality Expert

  Supplier, Third Part Laboratory and GMP Services Providers qualifications and Data management andmonitoring:- Accountable for communication with Supplier, Third Part Laboratory and GMP ServicesProviders- Lead Material Review Committee meetings ( Change Notifications and Deviations Impact)- Owner of annual External Audit Plan for Siena site, establish with global colleagues NovartisVaccines Audits planning.- Execute planned and for cause audits as support to Senior Auditor, including reports wrap up- Quality Info Record Management in SAP System (change status of raw material and codes)- Compile Annual Product Review Show less

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  Milkithchen restaurant

  Apr 2015 - Jul 2015

  Waitress

  Sales, customer service, coffee machine.

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  GlaxoSmithKline Pharma GmbH

  Aug 2015 - Dec 2016

  Change Management & Validation with Change Control Coordinator level 2 & QA Approver level 2certificated.- Understand the business needs and translate them in actions evaluating their impact.- End to end Project management, focusing on quality aspects, mainly about Aseptic areas,including Tech transfer, Decommissioning and Integration projects- Change management using Project management tools(i.e. Gannt, fishbone, RACI matrix and SixSigma basis tools)- Stakeholders management: internally and externally communication and member of matrixteam- Member of Site CCRB (Change Control Review Board) interacting with Operational Mangers,Process Unit heads and QA- Accountable in back office during Health Authorities (including FDA) Inspection audits- Ensure processes are aligned on cGMP and company Quality policies Show less Complaints Management: Pharmaceutical Technical Complaint (PTC) and Adverse Event managementand monitoring.- Complaint management as Lead Investigator II: overall criticality evaluation, investigation plan,root cause analysis (i.e. Fault Tree Analysis, 5 Whys), manage further specific investigations withfocus on departments and other manufacturing sites/Third parties, state conclusion, checkingand finalizing investigation report to submit to Health Authorities. Define and manage CAPA/CIAfor all justified complaints.- Adverse Event management: performing Standard and Expanded Batch Review in collaborationwith Pharmacovigilance.- Supplier management as SPOC for internal investigation.Trend analysis/KPI: monitoringperformance, collecting relevant data and producing statistical reports, using OperationalExcellence principles and Six Sigma tools.- Training supervisor: responsible of team qualification status.- Update of Standard Operation Procedures and Technical Reports.- Compile Annual Product Review Show less

  • QA Engineering & Validation Expert

    Mar 2016 - Dec 2016

  • QA Complaint Expert

    Aug 2015 - Feb 2016
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  Halozyme Therapeutics, Inc.

  Sept 2018 - Feb 2020

  QA Specialist / Responsible Person Deputy

  • Deputy of Halozyme CH site QP, releasing Drug Substances, Drug Products and Final Products in End-to-End process.• Support commercial lunch of Clinical Products.• Ensure cold chain, all transfers and storage are performed in compliance with GDP requirements.• Raise missing processes to ensure compliance with Health Authorities requirements.• SPOC for CMOs, related qualification and QA/QC management (e.g.: QA Agreement, Audits, Risk assessment).• CMO’s and company Change Controls, Deviations and CAPAs: End to End management. Show less

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  Novartis Gene Therapies

  Feb 2021 - now

  Cell Therapy Operations Manager

  • SPOC and accountable for the clusters Italy, UK, Ireland, WEC, Israel, Romania and Spain including operations management and customer facing.• End-to-End commercial and clinical orders management, including logistics aspects, continues improvements challenges of the process, considering pro / cons and related risk for each plan.• Lead and drive strategic meetings country specific.• On Demand Customer live support providing guidance through the CAR-T process and driving internal/external stakeholders (influencing them without authority) to fix ASAP any E2E issue.• Create and maintain the Work Instructions to harmonize and standardize the EU commercial process.• Cleaning and harmonization project.• Subject Matter Expert (SME) for OOS, Termination, Cancellation and Procedures.• Accountable for EU Customer Service Center during Health Authorities (i.e. Swissmedic, FDA) audits.• Continuously improve the performance providing innovative solutions to enhance customer experience and provide a better service for the patients. Show less