Ravi Kumar Ravi Podili P

About Ravi Kumar Ravi Podili P

With over 18 years of experience in the pharmaceutical and biotherapeutic industries, I specialize in Quality Assurance, Qualifications & Validations, and regulatory compliance across sterile, vaccine, and OSD manufacturing facilities.I bring hands-on expertise in commissioning, qualification, and validation of facilities, utilities, and equipment — including Installation Qualification (IQ), Operational Qualification (OQ), and validation lifecycle management. I author, review, and manage documentation such as URS, FRS, DS, and validation summary reports, ensuring compliance with GMP, GAMP, and Data Integrity standards.I have successfully led shop floor validation teams, ensured day-to-day compliance, and implemented strategies for resource optimization, cost reduction, and continuous improvement aligned with USFDA, EU-GMP, ANVISA, and WHO guidelines.I provide training, risk assessments, and change control support, ensuring validation deliverables meet regulatory and organizational objectives.My career spans leading organizations such as Eugia Pharma Specialties Ltd, Sanofi Healthcare India Pvt. Ltd, Bharat Biotech International Ltd, Zenotech Laboratories, and Gland Pharma Ltd.Key Achievement: Successfully contributed to a USFDA audit with zero observations, demonstrating a strong commitment to quality and compliance.Currently on an H1B visa, I am open to opportunities in the U.S. pharmaceutical and biotherapeutic sectors.

Experience

1. Validation Engineer

   MSN Pharmaceuticals Inc.

   Jun 2024 — Present · Piscataway, NJ, US

   Lead and execute commissioning and qualification (CQV) activities for equipment, facilities, and utilities in compliance with cGMP, FDA, and EU regulatory standards. Develop and review qualification protocols (IQ/OQ/PQ), test scripts, and related documentation.Coordinate and assign work order numbers for maintenance, calibration, and corrective actions.Establish and manage preventive maintenance (PM) schedules to ensure equipment reliability and minimize downtime.Prepare and monitor calibration schedules for instruments, ensuring traceability and compliance with standards. Implement and maintain Quality Management System (QMS) processes—change control, deviation management, CAPA, and document control.Oversee utilities monitoring and performance tracking including water systems (Purified Water, compressed air, and pure steam systems.•Support engineering and production teams by troubleshooting utility and equipment issues to ensure continuous operation.Participate in internal and external audits, ensuring readiness and compliance of engineering and utility systems.Drive continuous improvement initiatives in maintenance, calibration, and qualification practices to enhance efficiency and compliance.

Education

• University of Madras

  Master's degree, Biotechnology

  2005 — 2007

• University of Madras

  Master , Biotechnology