Valentina Rufolo
Siena
Summary
Highly enthusiastic CSV consultant, recognized for efficiently completing tasks and ensuring compliance with all regulatory standards. Possesses specialized skills in validation protocols, risk assessment, and documentation management. Strong experience in organic chemistry, as well as good expertise in the synthesis of small molecule drug-linker constructs for conjugation with monoclonal antibodies for the development of ADCs. Deeply committed to using her skills and expertise in opportunities that will allow her to contribute to high-impact projects.
Overview
2
2
years of professional experience
Work History
CSV Consultant
C&P Engineering
Florence
03.2024 - Current
- Provide and execute test scripts, generate traceability matrices, and perform CSV protocol execution.
- Develop, execute, and support validation documents (System Testing, IQ, OQ, PQ, UAT) and various CSV tasks.
- Engage in project activities, create planning documents and testing protocols, review test results for improvement, and modify SOPs. Analyze validation data and compile reports as needed.
Validation Specialist Consultant
Akkodis
Siena
08.2023 - 12.2023
- Developed and maintained validation procedures for software systems and equipment.
- Performed system validations to ensure that new or modified systems met user requirements.
Graduate Research Fellow
University of Siena
Siena
01.2023 - 07.2023
- Performed laboratory experiments related to organic chemistry, such as synthesizing and purifying compounds.
- Assisted in the preparation of samples for analysis using chromatographic methods.
Education
2nd Level Master Degree - Pharmaceutical Technologies And Regulatory Affairs
University of Pavia
Pavia12-2024
Master's Degree - Sustainable Industrial PharmaceuticalBiotechnology
University of Siena
Siena10-2023
Bachelor's Degree - Chemistry
University of Salerno
Salerno10-2020
Skills
- Antibody drug conjugate
- Critical Thinking
- Data Analysis
- Organic Synthesis
- Problem-solving aptitude
- Process Validation
- Regulatory Compliance
- Team Collaboration
Languages
Italian
First Language
English
Upper Intermediate (B2)
B2
French
Advanced (C1)
C1
Others
- Driving License B
Timeline
CSV Consultant
C&P Engineering
03.2024 - Current
Validation Specialist Consultant
Akkodis
08.2023 - 12.2023
Graduate Research Fellow
University of Siena
01.2023 - 07.2023
2nd Level Master Degree - Pharmaceutical Technologies And Regulatory Affairs
University of Pavia
Master's Degree - Sustainable Industrial PharmaceuticalBiotechnology
University of Siena
Bachelor's Degree - Chemistry
University of Salerno
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