Serialization Systems (ACF, UDI, OLV)
Process Validation specialist with hands‑on experience in validating manufacturing processes and digital systems, including serialization platforms (ACF, UDI, OLV) and eDHR. Strong capability in CSV activities, audit‑ready documentation, and ensuring data integrity in regulated environments. Skilled in remote collaboration, problem‑solving, and delivering reliable validation outcomes in fast‑paced settings.
• Demonstrated strong competency in computer system validation by leading end‑to‑end qualification (IQ/OQ/PQ) of Serialization, ACF, OLV, and automation systems, applying methodologies aligned with GAMP 5 and GxP requirements.
• Ensured data integrity and full traceability by supporting the implementation of serialization and product‑authentication platforms Serialization/ACF/OLV/UDI), contributing to secure, compliant, and audit‑ready digital manufacturing processes.
• Supported the creation, review, and critical evaluation of evidence‑based validation documentation, enabling timely and compliant market release of products under new technology implementations.
• Coordinated with vendors and cross‑functional engineering and quality teams to identify system issues, assess risks, and implement corrective and preventive actions (CAPA), ensuring ongoing system compliance and operational continuity across serialization and related digital systems.
CSV
VMP
URS/FS/DS
Change Control
Validation (Process/Product/Automation)
Serialization Systems (ACF, UDI, OLV)
Remote Work Skill
Minitab
Serialization Systems (ACF, UDI, OLV)
EDHR system
Adobe Sign
Team/Zoom
SAP
Minitab
Digital manufacturing systems
Automation technologies
Regulatory compliance learning
Remote teamwork
Data‑driven problem solving