Jim Hegidus
Validation Analyst Sr @GOJO, Makers of PURELL
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WORK HISTORY
Validation Analyst Sr @GOJO, Makers of PURELL
Cuyahoga Falls, OH, US
EDUCATION
Kent State University
BS, Physics with Computer Hardware
SKILLS
ABOUT JIM HEGIDUS
With over three decades of experience in the pharmaceutical and hygiene manufacturing industries, I specialize in ensuring compliance, data integrity, and operational excellence through robust computer system validation (CSV) practices. My expertise spans GAMP 5 methodologies, 21 CFR Part 11 compliance, and electronic records and signatures (ERES), supporting both legacy systems and modern cloud-based platforms.I bring a deep understanding of regulatory expectations and quality systems, having led validation efforts for enterprise software, laboratory systems, and manufacturing execution systems (MES). My approach is risk-based, audit-ready, and aligned with current Good Manufacturing Practices (cGMP).I help bridge the gap between IT and Quality, ensuring that digital transformation initiatives meet stringent regulatory requirements without compromising efficiency or innovation.
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