Romualdo Varricchio

Key Responsibilities & Achievements

Project: Personalized viral-based vaccine (Phase II clinical studies)

Objectives:
Ensure full compliance with GMP requirements, support timely batch release, and manage analytical method validation lifecycle in accordance with ICH guidelines, contributing to overall Quality System effectiveness.

• Performed GMP-compliant data review and verification of analytical results, ensuring accuracy, traceability, and regulatory compliance prior to QA approval
• Conducted analytical method validation and qualification (ELISA, infectious titer), applying statistical evaluation of validation parameters
• Authored and maintained documentation: SOPs; Validation protocols and reports; Change Controls
• Managed QC shipment documentation (TISF, MSD, CoA), ensuring completeness, traceability, and audit readiness
• Supported batch release activities, ensuring timely and compliant delivery of results
• Participated in deviation and OOS/OOT management and CAPA processes, contributing to root cause analysis and effectiveness checks
• Supported internal and external audits, ensuring documentation readiness and compliance with data integrity standards
• Applied data integrity principles (ALCOA+) across all GxP activities
• Collaborated cross-functionally with QA and Manufacturing, contributing to continuous improvement of quality processes

Key Competencies Developed

Quality Systems & Compliance

• GMP compliance and regulatory awareness (FDA, EMA, ICH, ISO 9001)
• Basic understanding of Quality Management Systems (QMS)
• Audit readiness and inspection support
• Documentation control and lifecycle management

Deviation & CAPA Management

• OOS/OOT investigation support
• Root cause analysis (RCA)
• CAPA implementation and follow-up

Documentation & Data Integrity

• SOP writing and document revision
• Change Control management
• Batch record review and traceability
• Data integrity (ALCOA+) application

Analytical method Validation and Method transfer

• Authored Validation protocol and reports
• Statistical evaluation of validation parameters

Project: Production of innovative toxin detection method using THz—Time domain spectroscopy.

Tasks:

• Development of an albumin-based biosensor platform for the detection of bacterial toxins using THz—Time Domain Spectroscopy.
• Assessment and optimization of biofunctionalization strategies to enhance sensor performance.
• Co-authored peer-reviewed articles on innovative protein–ligand interactions detection methods, biofunctionalization strategies, and biosensor development.

Project: Production of innovative bacterial-based hydrogel, assessment of COVID-19 detection methods

Objectives: Selective oxidation of bacterial derived cellulose, develop innovative COVID-19 detection methods

Tasks:

• Oxidation and structural characterization of bacterial derived cellulose
• Antibiofilm and repair activity assessment of ophthalmic products
• Development of innovative SARS-CoV2 detection methods
• Assessment of Sample-Pooling strategy for SARS-CoV-2 detection
• Cell culture
• Cell-based assays
• Bacterial culture