Harshith Raj Muniraj

About Harshith Raj Muniraj

Currently working as a Quality Assurance Validation Specialist at Amgen, Rhode…

Experience

1. Quality Assurance Validation (Qav) Specialist

   Amgen

   Mar 2025 — Present · RI, US

   Provide QA oversight for commissioning, qualification, and validation (CQV) of critical GMP manufacturing systems, including buffer formulation skids (Buffer FS), bioreactors, pool tanks, chromatography columns, turbidimeters, and -75°C freezers.• Review and approve validation lifecycle documentation including User Requirements Specifications (URS), Installation/Operational/Performance Qualification (IQ/OQ/PQ) protocols, and final reports to ensure compliance with cGMP, FDA, and internal quality standards.• Actively participate in risk assessments and design qualification reviews for new equipment installations and system upgrades.• Perform QA review of line verification documents and ensure proper execution and documentation for equipment readiness in GMP manufacturing.• Ensure compliance with data integrity standards by reviewing audit trails and electronic records associated with process equipment and critical instrumentation.• Conduct periodic reviews of validated systems and equipment to assess continued state of control, ensuring timely revalidation as needed.• Collaborate with cross-functional teams including validation, engineering, automation, and manufacturing to provide real-time QA input during project execution and system startup.• Support change control activities by assessing validation impact and ensuring appropriate QA oversight throughout the lifecycle.• Maintain adherence to regulatory requirements and internal SOPs during validation activities, documentation, and system reviews.• Provide QA guidance during deviations and CAPA investigations related to validation and equipment performance.

Education

• Texas Tech University

  Master's degree

• Sir M Visvesvaraya Institute Of Technology

  Bachelor of Engineering - BE