Virendra Rana

About Virendra Rana

Experienced Quality Specialist with a demonstrated history of working in the Biopharmaceuticals industry for 15 years supporting manufacturing and regulatory compliance operations. Strong scientific professional and skilled in cGMP operations, Change Controls, Regulated Document Management, Deviation Management, Manufacturing Batch audit review and dispositions, QA walkthroughs, process changeovers as well as Regulatory inspections.

Experience

1. Principal Validation Engineer

   Sanofi

   Dec 2024 — Present · Ridgefield, NJ, US

   Advanced understanding of 21CFR Part 11, cGMP, and other regulatory guidance for manufacturing equipment and automated processing systems• Author and execute IQ, OQ, PQ (Installation, Operational, and Performance Qualification) protocols, Support system change management, deviation investigations, and CAPAs related to the CSV activities. Collaborate with IT, Quality Assurance, and Regulatory Affairs teams to ensure validation requirements are met• Ensure validation activities align with GAMP and other industry standards. Conduct risk-based commissioning, qualification, and validation approached that meet current regulatory requirements, internal standards, and industry practices• Manage the document Lifecycle Approach, including creation and revision in compliance with document management system. • Demonstrate ability to generate CSV deliverables independently. Prepare and maintain User Requirements, Functional Requirement. Show ability to manage medium to complex CQV projects.• Capability to work both independently and in a team environment. Strong interpersonal, organization and technical skills.• Proficiency in Microsoft Office including Word, Excel, PowerPoint, and Project and Visio

Education

• Montclair State University

  Master of Science, Chemistry / Biochemistry

  2007 — 2009

• Rutgers University

  Bachelor of Science, Biochemistry

  1999 — 2004