Chintal Mehta

Background

About Chintal Mehta

Business Professional with a Successful Track Record in: • Business Relationships: Fostering and sustaining robust business relationships through cross-functional collaborations and matrix environments. • Regulatory Compliance: Quality and compliance, GxP, SOPs, FDA regulations (including CFR part 11). • Quality Systems: SME for training activities and applications like LSM, Electronic Document management system, Veeva (for Change Control, QTP, Suppliers, and Materials management), and KPI reporting and tracking, • Process Improvement: Lean leader and coach, operational excellence. • Project Management: Effective project management skills with leading and managing projects. • Training: Developed and delivered comprehensive training programs, enhancing training based on specific job roles. • Software Proficiency: Skilled in LMS, Documentum, publishing tools, Adobe Acrobat with ISI toolbox, and MS Office. • Computer Validation: Experienced in OQ, PQ, and troubleshooting. Continuous Improvement: • Activities included, but not limited to, managing the various electronic, validated & Part 11 compliant Quality Management System processes including document management, internal/external audit/inspection readiness program, Change Control, supplier/vendor qualification/audit program • Leading and supporting local and global teams for process harmonization and improvements with electronic document management, and regulatory compliance by managing preclinical protocols, data and reports. • Supporting third-party quality management. • Providing operational and technical support to R&D Site Quality Operations teams for site quality event management. • Supporting the management of R&D Quality Documents at a multisite level. • Promoting a quality culture within and outside the quality department. This summary highlights my comprehensive expertise and achievements in process improvement, regulatory compliance, project management, training, and quality management, along with technical proficiency and leadership in continuous improvement initiatives.