Marianna Amato

Quality Assurance & Regulatory Affairs Manager at Nical S.p.A.
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Contact Information
us****@****om
(386) 825-5501
Location
IT
Languages
  • English Full professional proficiency
  • Deutsch Elementary proficiency
  • Italiano Native or bilingual proficiency
  • Kiswahili Elementary proficiency
  • Español Elementary proficiency
  • Français Elementary proficiency

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Credentials

  • La norma EN ISO 13485:2016 - Attestato di Competenza
    TUV Italia Akademie
    Jun, 2021
    - Nov, 2024
  • Corso di Alta Formazione in Quality Assurance & GMP Compliance
    Quality Assurance Academy
    Mar, 2021
    - Nov, 2024
  • Attestato di Formazione Teorica in materia di Ambienti sospetti di Inquinamento o Confinati
    SGS
    Feb, 2019
    - Nov, 2024
  • CEFR C1
    Trinity College London
    Aug, 2017
    - Nov, 2024
  • Attestati Responsabile del Servizio di Prevenzione e Protezione RSPP
    UNINFORM GROUP e ANGQ
  • Attestato Consulente Progettista Privacy
    UNINFORM GROUP e ANGQ
  • Attestato Master Quality: Esperto in Sistemi di Gestione Aziendale Integrati - Qualità, Sicurezza, Ambiente, Energia
    UNINFORM GROUP e ANGQ
  • Attestato Progettista e Valutatore del Modello Gestionale D.lgs 231/01 e Basilea 2
    UNINFORM GROUP e ANGQ
  • Attestato Progettista, Responsabile, Auditor e Lead Auditor di Sistemi di Gestione Ambientale
    CEPAS
  • Attestato Progettista, Responsabile, Auditor e Lead Auditor di Sistemi di Gestione dell'Energia
    CEPAS
  • Attestato Progettista, Responsabile, Auditor e Lead Auditor di Sistemi di Gestione della Salute e Sicurezza nei luoghi di lavoro
    CEPAS
  • Attestato Progettista, Responsabile, Auditor e Lead Auditor di Sistemi di Gestione per la Qualità
    CEPAS
  • Attestato Responsabile Gestione dei Rifiuti
    UNINFORM GROUP e ANGQ
  • Attestato Valutatore Sistemista SA 8000
    UNINFORM GROUP e ANGQ

Experience

  • NICAL
    • Italy
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Quality Assurance & Regulatory Affairs Manager
      • Oct 2021 - Present

      Reporting to the General Manager, I am responsible for: - the implementation/mainteinance of the Quality Management System certified ISO 13485:2016; - the mainteinance of CE (Dir. 93/42/EEC) e FDA (CFR 21) certifications; - obtaining MDR certification (EU Reg. 2017/745); - Technical Assistance and Firmware/Software Testing&Validation processes. Reporting to the General Manager, I am responsible for: - the implementation/mainteinance of the Quality Management System certified ISO 13485:2016; - the mainteinance of CE (Dir. 93/42/EEC) e FDA (CFR 21) certifications; - obtaining MDR certification (EU Reg. 2017/745); - Technical Assistance and Firmware/Software Testing&Validation processes.

  • OMB Valves Group
    • Milano, Lombardia, Italia
    • QA/QC Specialist - Senior Document Controller
      • Oct 2020 - Oct 2021

      Coordinating a team of two Document Controllers, I was responsible for: - the implementation/maintenance of the Quality Management System (certified ISO 9001, API 6D, API 6A, PED) and ERP Software with regard to Quality Department structures; - planning activities for preparation, revision and release of the Batch Manufacturing Record Books; - managing the document approval process with the customer; - performing Internal Audits and cooperating with the QHSE Manager during Certification/Surveillance Audits; - obtaining the Product Certificates required for export and managing Prototype Tests related activities.

  • Bel Valves Srl - British Engines Group
    • Milano, Lombardia, Italia
    • QA/QC Specialist - Document Controller
      • May 2019 - Sep 2020

      Reporting to the QHSE Manager, I was responsible for: - the implementation/maintenance of the Quality Management System (certified ISO 9001, API 6D, PED) and ERP Software with regard to Quality Department structures; - verifying analytical certificates of incoming raw materials with regard to project requirements and coordinating the Quality Controller for material traceability checks; - the preparation of the Batch Manufacturing Record Books; - managing the document approval process with the customer; - obtaining the Product Certificates required for export and managing Prototype Tests related activities.

  • SIGEMI - SOCIETA A RESPONSABILITA LIMITATA
    • Italy
    • Oil and Gas
    • 1 - 100 Employee
    • QHSSE Engineer
      • Jun 2018 - Apr 2019

      Reporting to the QHSE Manager, I was responsible for: - the implementation/maintenance of the QHSE Management System (certified ISO 9001, ISO 14001, OHSAS 18001), collaborating to the updating of Procedures and Chemical Risk Assessment, analyzing the KPIs and preparing presentations for Annual Review; - performing Internal Audits; - performing External Audits on critical supplier; - managing Non-Conformities (in & out), Near Miss and Accident, CAPA plans and related data analysis activities; - collaborating to the preparation of Training Plans; - collaborating to the budget management for environmental analysis/monitoring. I have collaborated with the Purchasing Dept. Manager for the document management related to procurement and subcontracting contracts, and with the Maintenance Manager for Duvri related activities.

  • Insegnante privato
    • Teacher
      • Oct 2011 - Feb 2018

      Private Teacher of Math, Physics, Chemistry, Music Private Teacher of Math, Physics, Chemistry, Music

  • Università della Calabria
    • Italy
    • Higher Education
    • 700 & Above Employee
    • Trainee Researcher
      • Oct 2016 - Jul 2017

      Project: Optimization and characterization of innovative deposition protocols for gold nanoparticles monolayer. I have dealt with the preparation of nanoparticle solutions and devices in the Clean Room and with analysis and characterization of chemical-physical properties through Spectrophotometry, UV/Vis Spectrometry, Atomic Force Microscopy, Scanning Electron Microscopy, Ellipsometry, thermal analysis. Project: Optimization and characterization of innovative deposition protocols for gold nanoparticles monolayer. I have dealt with the preparation of nanoparticle solutions and devices in the Clean Room and with analysis and characterization of chemical-physical properties through Spectrophotometry, UV/Vis Spectrometry, Atomic Force Microscopy, Scanning Electron Microscopy, Ellipsometry, thermal analysis.

  • Università della Calabria
    • Italy
    • Higher Education
    • 700 & Above Employee
    • Trainee Researcher
      • May 2014 - Dec 2014

      Project: Homeotropic and planar dynamic alignment of chromonic liquid crystals. I have dealt with the preparation of liquid crystals solutions and devices in the Clean Room and with analysis and characterization of chemical-physical properties through Polarized Light Microscopy and contact angle measurements setup. Project: Homeotropic and planar dynamic alignment of chromonic liquid crystals. I have dealt with the preparation of liquid crystals solutions and devices in the Clean Room and with analysis and characterization of chemical-physical properties through Polarized Light Microscopy and contact angle measurements setup.

Education

  • TUV Italia Akademie
    Training Course, ISO 13485:2016
    2021 - 2021
  • QA Academy - Business School
    Advanced Training Course, Quality Assurance & GMP Compliance
    2021 - 2021
  • Master Quality - Uninform Group
    Post Graduate Education Cours, Advanced training course for Integrated Management Systems Specialists – QHSE & Energy
    2017 - 2018
  • Università degli Studi della Calabria
    Master's degree, Innovative and Functional Material Science and Engineering
    2015 - 2017
  • Università degli Studi della Calabria
    Bachelor's degree, Innovative Material Science and Nanotechnology
    2011 - 2014
  • Classical High School
    Classical High School Diploma, 100L
    2006 - 2011
  • Conservatory of Music
    Clarinet
    2004 - 2011

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