Judit Varga

Background

About Judit Varga

Leveraging over a decade of experience in pharmaceutical and biotech industries, I specialize in Data Integrity, Computer System Validation (CSV), and regulatory compliance. My expertise spans conducting comprehensive data integrity assessments, managing CAPAs, and leading cross-functional teams to implement robust validation and remediation strategies. With a proven track record in overseeing regulatory inspection readiness and executing validation protocols (FAT, SAT, IQ, OQ, PQ), I have significantly enhanced compliance frameworks and reduced operational risks. Adept at developing SOPs, delivering targeted training programs to diverse teams, and managing projects,I combine technical proficiency with a collaborative leadership style. My roles have consistently resulted in improved compliance, operational efficiency, and audit readiness, making me a valuable asset in regulated environments. Previous positions held: Data Integrity Expert / Senior QA / CSV Consultant / Senior Data Integrity Expert / Senior QA Specialist / CSV Engineer / Data Integrity Site Project Lead / Validation Engineer. Below are some of the key accomplishments that I have attained: Conducted comprehensive Data Integrity Assessments and implemented CAPAs for COVID-19 vaccine production equipment-(Janssen Biotech) Led a QA Validation Team of 16, executing CSV remediation strategies and supporting regulatory inspections-(GSK Pharmaceuticals) Delivered training programs to 300+ employees, enhancing organizational Data Integrity awareness and reducing review times-(Odyssey VC) Expertise / Skills: Data Integrity / Computer System Validation / Equipment Qualification / CAPA / Regulatory Compliance / GxP / GAMP5 / FDA Inspections / Risk Mitigation / Audit Readiness / SOP Development / Training Programs / Validation Protocols / FAT / SAT / IQ / OQ / PQ / Change Control / Deviation Investigation / Laboratory Systems / Manufacturing Systems / LIMS / SAP / TrackWise / Data Integrity Governance / ISO 9001:2015 / Annex 11 / 21 CFR Part 11 / Biotech Production / Technical Leadership / Cross-Functional Collaboration / Remediation Strategies / Continuous Improvement / CSV Project Management / Process Validation / Quality Assurance / Regulatory Inspections / Audit Trail Reviews / User Access Reviews / Corrective Actions / Preventive Actions / Technical Documentation / Validation Master Plan