Maulik Bhatt
Computer System Validation (Csv) Engineer @Verista
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WORK HISTORY
Computer System Validation (Csv) Engineer @Verista
OH, US
Develop, implement, and review computer systems validation (CSV) protocols to ensure all GxP (Good Practice) computer-based systems operate correctly and comply with regulatory standards.• Author and maintain comprehensive validation documentation, including validation plans, risk assessments, test scripts, and summary reports, ensuring adherence to industry regulations and guidelines.• Ensure that all computerized systems comply with relevant regulations, such as FDA cGMP, 21 CFR Part 11, and GAMP 5 guidelines, maintaining data integrity and security.• Oversee the installation, configuration, and testing of computerized systems, for laboratory equipment, to confirm they meet user requirements and function as intended.• Work closely with project teams, system owners, and other stakeholders to provide guidance on CSV strategies, ensuring seamless integration and compliance across departments.• Provide support to staff on computerized systems and validation protocols, ensuring adherence to relevant procedures and regulatory requirements.• Provide CSV support for Change Actions and CAPAs associated lab equipment.• Perform CSV impact assessments for lab equipment project change controls. • Assist/advise BPOs in the development of strategy that pilots and implements DI compliant system. • Author and support GxPCCA and Audit Trail Assessment for lab systems.
EDUCATION
Gujarat University
BACHELOR'S OF PHARMACY, PHARMACEUTICS, PHARMACOLOGY,MEDICINAL CHEMISTRY,BIO-CHEMISTRY,BIO-TECHNOLOGY
University of Greenwich
Master of Science (MSc), Pharmaceutical Sciences
ABOUT MAULIK BHATT
Pharmaceutical quality professional with 14+ years of expertise in GMP/GLP-regulated environments, specializing in validation, compliance, and operational excellence.Core Competencies:• Regulatory Compliance: Deep knowledge of GMP guidelines and pharmaceutical regulatory requirements• Cross-Functional Leadership: Proven track record across Manufacturing, QA, QC, Supply Chain, Packaging, Validation, and Business Development• Operational Excellence: Skilled in implementing LEAN and OP-EX methodologies to enhance productivity while minimizing waste and costs• Project Management: Strategic planner with strong analytical and technical capabilities, experienced in leading multi-disciplinary projects from concept to execution
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