Federica Fiore
Roma
Summary
Extensive knowledge of pharmaceutical and/or medical device regulations, e.g., ISO 13485, ISO 9001, FDA cGMP, MDD, Eudralex, other global or regional equivalent. Working knowledge of US and International cGMP as it applies to the defined commodity portfolio. Experience in Product/process development and/or supplier quality improvement. Auditing skillsets
Business Acumen; knowledgeable in technology and information affecting pharma industry.
Collaboration and Teamwork: Good communications, facilitation, coordination and team skills. Project management skills managing multiple issues of moderate to high complexity relatively independently with minimal supervision/instructions.
Superior time-management skills. Superior written and oral communications skill sets. Willingness and ability to travel
Overview
8
8
years of professional experience
Work History
Global Senior Specialist Supplier Quality - EMEA
Baxter International Inc
09.2024 - Current
- Independently manages Supplier Quality Assurance and Maintenance activities for assigned suppliers and external contract manufacturers. Responsible for activities such as execution of quality assessments/audits, negotiation and implementation of Quality Agreements, monitor and reporting of metrics. Manage Quality and Compliance related issues between suppliers and the company.
- Performs Qualification of suppliers to medical device, pharmaceutical, combination devices, and/or biologics standards
- Participates or leads the preparation and/or review of standards, policies, procedures and guidelines that are used to establish quality requirements.
- Scheduling, preparing, conducting and reporting Global Quality audits.
- Assists in preparing for and defending Purchasing Controls in inspections by external agencies or internal company audits of Purchasing Controls processes. Manage and oversee Purchasing controls CAPA, including root cause identification, and effective and timely closure. Develop and/or deliver training to internal teams and suppliers, administer training systems. Execute SCAR management, effective and timely closure and Review/risk assessment of Supplier Quality Notifications and their escalation to SCARs and NCR where needed. Accountable for NCR (non-conformance reports) as assigned, conducting NCR timeliness and effectiveness reviews, and trending for corrective/preventive actions.
Manufacturing Quality Assurance
AbbVie
11.2021 - 08.2024
- Overall management of Third Parties products: Change Requests, Exception Reports, Process Deviations, Investigations and CAPAs. Management of site quotations for Third Parties projects. Ensuring the implementation of local external requirements in the site quality systems.
- Knowledge of Product storage and distribution processes; Stability studies monitoring and stability protocols drafting; External and Internal Audit Support;
- Assuring compliance to Third Party regulations and dossiers; Actively partecipation in Technology Transfer projects, Process Validation and New market extension process.
Batch Record Reviewer and Line Ispector
AbbVie
10.2020 - 10.2021
Quality Intern
Altergon Srl
05.2020 - 09.2020
Pharmacovigilance Trainee
Centro Regionale Di Farmacovigilanza
01.2018 - 03.2020
Education
Master Universitario Di II Livello - Pharma&Healthcare Administration And Management
Luiss Business School
Rome, Italy11-2023
Pharma Doctor - Pharmacy
Universtà Federico II Di Napoli
07-2020
Master Degree - Pharmacy
Università Federico II Di Napoli
03-2020
Skills
Experience in root cause analysis, corrective and preventive action methods; Expertise/experience in problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA / 5WHY etc
Experience with data analysis and reporting using basic Excel toolkit and advanced statistical /process packages such as Minitab or Visio and PowerPoint
Timeline
Global Senior Specialist Supplier Quality - EMEA
Baxter International Inc
09.2024 - Current
Manufacturing Quality Assurance
AbbVie
11.2021 - 08.2024
Batch Record Reviewer and Line Ispector
AbbVie
10.2020 - 10.2021
Quality Intern
Altergon Srl
05.2020 - 09.2020
Pharmacovigilance Trainee
Centro Regionale Di Farmacovigilanza
01.2018 - 03.2020
Master Universitario Di II Livello - Pharma&Healthcare Administration And Management
Luiss Business School
Pharma Doctor - Pharmacy
Universtà Federico II Di Napoli
Master Degree - Pharmacy
Università Federico II Di Napoli