Experience

UPS Healthcare

• United States
• Transportation, Logistics, Supply Chain and Storage
• 400 - 500 Employee

• Quality Assurance Specialist

  • May 2022 - Present

  This position monitors the overall Quality System status of the distribution center. This position acts in compliance to drug, medical device, and local regulations. Ensures quality processes are maintained through the implementation of procedures, training, and regular inspections. - Assist with the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and 13485 standards, and in compliance with the EU GMP and EU GDP Guidelines - Provide training, ensure the training needs are met and coordinate the trainings for the staff. - Monitor, conduct and coordinate self-inspections to ensure compliance with GMP, GDP and ISO 9001 and 13485 requirements - Participate and assist in supplier audits and provide evaluation of suppliers - Provide support for investigation into non-conformances and customer complaints - Follow-up on all Corrective Actions and Preventive Actions (CAPAs) - When delegated to do so by Healthcare Compliance (QA) Management or RP/QP, decides on the final disposition of finished products, returned and rejected products - Assist in the maintenance of documentation in accordance with the EU GMP/ EU GDP Guidelines, and the relevant standards - Ensure that the operations performed at the facility (reception, inspection receipt, storage, picking and shipping) are made in accordance with the approved procedures/ work instructions - Conducts Quality Management System Reviews - Ensure equipment calibration and maintenance program are met - Collection of Temperature Data and Monitoring of the temperature environmental conditions - Promote a “quality” culture within the company - Auditing activities Show less



ERBC (European Research Biology Center)

• France
• Biotechnology
• 100 - 200 Employee

• QA Auditor

  • Sep 2021 - May 2022

  Job description:- GLP/GCP Study Review;- GLP/GCP Protocol Review;- Performing internal audit to processes, equipment and personnel;- Internal inspections;- Back up coordinator dept.;- Evaluating risk-based monitoring results, trends and remediation and applicable internal audit outcomes (CAPAs);- Supplier Quality Management; Performing audits to local suppliers (product, logistic or medical services) and local contract manufacturers following the Company and GLP QMS;- Establish and maintaining the Local Quality System Management System, in compliance with ERBC QMS and in line with EU,USA and National rules (21 CFR, GLP principles,OECD);- Equipments maintenance- Report and Documentation review;- FMEA risk based approach; - Risk analysis;- Local SOP (s) Management;- Archiving ops- GxP guide Show less

• QA Technician

  • Jun 2020 - Sep 2021

  Job Description:- Establish and maintaining the Local Quality System Management System, in compliance with ERBC QMS and in line with EU,USA and National rules- Report and Documentation review- Performing internal audit to processes, equipment, and personnel- Handling of non-conforming products, complaints and processes non-conformities- Supplier Quality Management, FMEA risk based. Performing audits to suppliers- Local SOP (s) Management



COSMI ITALIA SRL

• Italy
• Personal Care Product Manufacturing
• 1 - 100 Employee

• Quality & Compliance Chemicals & Packaging Components

  • Jan 2020 - May 2020

  Assicurare standard di qualità dei prodotti Cosmi, standardizzando i processi di formulazione e product released. Promozione di know-how tecnico sui materiali, redazione del CPNP per il prodotto finito, preparazione di specifiche tecniche: - Lead al controllo e rilascio dei materiali.Analista dei materiali in incoming, batch released.Allineamento di conformità ai requisiti regolatori: GMP, CFR, Pharmacopeia - Supporto tecnico al team locale - Audit interni - Tracciabilità del process workflow in SAP - Supporto nella qualifica e selezione dei fornitori - Verificare la disponibilità dei materiali richiesti per l’esecuzione dei protocolli di convalida - Regulatory Compliance - Production coordinator Show less



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Project Leader Coordinator, R&D- Raw Material Center-

  • Oct 2018 - Dec 2019

  Provide technical support, evaluating impact of changes related to current raw material portfolio.Work with other global leads and functions to develop and manage Global Change Controls for multiple raw material.- Develop GCC Plans and Deliverables and own Execution of the GCC- Prepare lab batches of semi-solids and liquid product to assess equivalency- Coordinate and interact with various internal departments such as, Procurement, Analytical, IM\EM sites, QA, Regulatory and Tox, Claims and Suppliers. - Interaction with different stakeholders- EHS impacts on raw materials- Ensure business continuity and compliance- Reviewer of data- Owner of Technical document- Standard Operating ProcedureComparison of different analytical requirementsManage project timeline Show less

• Quality Assurance Intern

  • Dec 2017 - Sep 2018

  Progetto principale: Product Quality Review (strumento di revisione di tutti i prodotti e semilavorati). Coordinamento di tutte le attività di raccolta e valutazione dei dati per l’emissione dei PQR in accordo al APR. Attività operative di routine del QA:- Owner dei Liquids Filling Line Quality Control - Monitoraggio dei KPI del sistema di qualità- Organizzazione, svolgimento e documentazione follow-up degli internal audits in accordo alle SOP di riferimento- Revisione di protocolli GMP; protocolli 21 CFR- Revisione e archiviazione di documentazione inerente la produzione: Batch Record Review- Elaborazione e gestione di certificati di conformità tramite gli strumenti informatici previsti (LIMS, BPCS)- Gestione di Deviazioni, OOS e supporto per l’implementazione delle azioni CAPA- Aggiornamento e stesura procedure operative standard (SOP)- Ensure Data Integrity and adherence to GxP guidelines Show less



Federazione Italiana Nuoto

• Spectator Sports
• 100 - 200 Employee

• Jr Marketing Assistant

  • Jun 2013 - Jun 2017

  - Attività di Blogging e SEO - Gestione operativa dei social media - Gestione del piano editoriale - Customer care - Monitoraggio e interpretazione dati - Attività formative, informative e tecniche delle discipline natatorie - Organizzazione manifestazioni e competizioni natatorie - Attività di Blogging e SEO - Gestione operativa dei social media - Gestione del piano editoriale - Customer care - Monitoraggio e interpretazione dati - Attività formative, informative e tecniche delle discipline natatorie - Organizzazione manifestazioni e competizioni natatorie



Centro Sportivo Italiano

• Italy
• Sports Teams and Clubs
• 100 - 200 Employee

• Istruttore tecnico

  • Sep 2012 - Jul 2016