Carmen Barbaria
Frosinone
Summary
Experienced Computer System Validation specialist with proven experience in validations of computerized production and laboratory systems. Expert in ensuring compliance with current international regulations, including EU GMP Annex 11 and FDA 21 CFR Part 11. Proficient in navigating complex regulatory environments, with a strong commitment to operational excellence and data integrity.
Overview
4
4
years of professional experience
Work History
CSV & Data Integrity Specialist
Thermo Fisher Scientific, Patheon
06.2023 - Current
- Manufacturing and Laboratory CS validation projects management from design and implementation to maintenance and decommissioning, in line with Annex 11 and 21 CFR Part 11 standards
- Collaborate closely with IT, quality assurance, operations, and laboratory teams to ensure a seamless and integrated approach to the validation and ongoing management of computerized systems
- Enhanced overall data integrity with regular audits and updates to maintain accurate information
- Supported regulatory compliance efforts with meticulous documentation and adherence to industry standards
- Led validation of equipment and utilities in new sterile departments, including SCADA systems, HVAC units, climatic chambers, solution preparation units, particle counters, filling lines, and packaging systems.
- Experience in the sw validation of various instruments and systems used in analytical and laboratory environments, including HIAC, UV-Vis spectrophotometer, LIMS , CCI Tester, E-notes, atomic absorption spectrometer, TOC analyzer, SoloVPE, oxygen analyzer, stability chambers, dynamometer, and densimeter.
- Managed documentation and test execution, including configuring and documenting systems (SDS, TM, VPL, RA, SC, IOQ, VR), supervising supplier-executed tests (FAT, SAT), and conducting internal IOQ protocols to ensure compliance with regulatory requirements and relevant guidelines
CSV Consultant
Akka Technologies
04.2021 - 06.2023
- Validation documentation, including validation master plans, risk assessments, test plans, and detailed test cases, ensuring clear, concise, and effective communication of validation activities and outcomes
- Execute testing protocols with precision, overseeing both automated and manual tests to verify system functionality, reliability, and compliance with specified requirements
- Record and analyze test data to identify system defects, inconsistencies, and areas for improvement
Education
Master's Degree - Pharmaceutical Chemistry
University of Salerno
04.2021
Roles And Responsibilities
- Planning, developing, and implementing comprehensive validation strategies for computerized systems according to Annex 11 and 21 CFR Part 11 standards, ensuring adherence to all applicable regulations.
- Conducting in-depth risk analyses to identify potential system vulnerabilities and developing recommendations for enhancements in security and compliance.
- Drafting and reviewing detailed validation documentation, including validation plans, functional specifications, qualification protocols (IQ, OQ, PQ), and validation reports.
- Working closely with cross-functional teams, including product development, quality assurance, production, and laboratory, to ensure a coherent and integrated approach to system validation.
Languages
Italian
English
Timeline
CSV & Data Integrity Specialist
Thermo Fisher Scientific, Patheon
06.2023 - Current
CSV Consultant
Akka Technologies
04.2021 - 06.2023
Master's Degree - Pharmaceutical Chemistry
University of Salerno
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