Umesh Babariya Email & Phone Number

Framingham, Ma, Us

Bedford, Ma, Us

Lead validation lifecycle including execution of revalidations and periodic system review. Create, implement, and maintain Validation Master Plan (VMP) for the organization, ensuring all validation activities are well-documented and aligned with regulatory requirements.Conduct risk assessments and implement risk mitigation strategies for validation activities. Participate in internal or external audits to support closure of observations and audit items.Investigate and manage deviations, non-conformances, and CAPAs (Corrective and Preventive Actions) related to validation.Supervise validation contractors and outside vendors to meet project timelines, goals and milestones.Monitor and analyze quality validation metrics and trends to drive continuous improvement.Communicate validation status, issues, and results to stakeholders and senior management.

Paris, France, Fr

Paris, France, Fr

Managed Critical Materials Management (CMM) and Point-of-Fill Filtration Projects.Led qualification, validation, and revalidation projects of Single Use System (SUS) consisting of bags, tubing, and filters. Generated qualification deviations/CAPAs, performed investigations, and root cause analysis. Collaborated with internal groups and supported non-conforming material issues resolution with suppliers.

Paris, France, Fr

Led, supported, and executed Continuous Improvement (CI) projects for Biologics Manufacturing.

Led and Managed Production/Quality lean and continuous improvement projects.Redesigned and rewrote URS, IQ, OQ & PQ protocols related to equipment and facility.Validated new manufacturing equipments and processes.Reviewed manufacturing batch records for all manufacturing processesPerformed Out-of-Specification (OOS) Investigation, CAPA and wrote OOS reports.

Nanterre, Île-De-France, Fr

Master'S Degree, Project Management

Master’S Degree, Mechanical Engineering (Industrial And Systems)

Bachelor’S Degree, Aeronautical Engineering