Hitesh Gandhi
Project Leader | AI-Driven Project Management | Driving Digital Transformation in Pharma | SAP, QMS, LIMS & Audit-Ready Digital Solutions
- Role
- Principal Consultant - Quality Systems and Regulatory Compliance at Tractentec
- Location
- Chester Springs, PA, US
- LinkedIn followers
- 500 followers
About Hitesh Gandhi
Welcome to my LinkedIn profile: As a results-driven IT & SAP Project Management…
Experience
Principal Consultant - Quality Systems and Regulatory Compliance
Jun 2024 — Present · NJ, US
I help pharmaceutical companies design, implement, and continuously improve enterprise applications that support their quality systems. My goal is to make operations run smoother, boost compliance, and strengthen quality management across the board.In 2024, I earned my PMP, PMI-ACP, and ITIL certifications—adding even more structure and depth to the work I do.One of my proudest achievements was leading the development of a multi-phase, multi-year roadmap for a major pharma client’s Quality Management System. This initiative not only supported regulatory compliance but also prepared the company for inspections from both regulators and customers. Below are my notable accomplishments Phase 1: I led the creation and rollout of hands-on training programs and wrote detailed Standard Operating Procedures (SOPs) for all key quality processes—Deviation Management, CAPA, Change Control, Document Control, Customer Complaints, Audits (internal, external, and supplier), MRB, Annual Product Reviews, Preventive Maintenance, and Calibration. This helped the team achieve consistency and stay aligned with regulatory expectations. Phase 2: I took charge of evaluating QMS vendors and led a Make or Buy analysis to help the client choose the right digital solution. The outcome? A modernized, streamlined approach to quality management that improved both efficiency and compliance.
Education
M.S University, India
Master's degree, Life Science
1993 — 1995
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