Oleksandr Larkin

Background

About Oleksandr Larkin

Certified Computer Validation Manager and ISPE member, with extensive experience in CSV/CSA, quality compliance, and validation strategy across the CRO and pharmaceutical industries. A seasoned IT Validation and Quality expert, specializing in GxP compliance, audit readiness, and process management within highly regulated environments. Skilled in leading end-to-end computer system validation, test management, and business analysis, ensuring alignment with global regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5) while driving improvements in system quality, efficiency, and inspection readiness. Proven ability to deliver risk-based, scalable validation frameworks (CSV/CSA) that support both operational excellence and long-term quality strategy. Key Expertise: Strategic Validation Leadership: Proven expertise in Computer System Validation (CSV) and modern CSA approaches, with a focus on risk-based validation aligned with GxP, 21 CFR Part 11, GAMP 5, and EU Annex 11. Quality & Compliance Excellence: Strong command of Quality Management Systems (QMS), lifecycle oversight, and Data Integrity principles (ALCOA+), ensuring continuous audit readiness and regulatory alignment. Agile-Driven Validation Delivery: Experienced in leading cross-functional teams in Agile environments, leveraging tools like Azure DevOps, JIRA, and HP ALM to drive efficient, traceable validation processes. Process & Performance Optimization: Skilled at streamlining SDLC and STLC workflows in regulated environments, applying ITIL-based practices to improve compliance, efficiency, and system quality. Business & Stakeholder Alignment: Strong background in business analysis and stakeholder management—bridging the gap between business needs, technical implementation, and compliance requirements. Certifications & Tools: Certifications: Computer Validation, SAFe® Agilist, Scrum Master, ISTQB Test Manager, ISO 9001:2015 Tools: Azure DevOps, JIRA, Confluence, HP ALM/QC and other