Bhuvaneshwaran A Email and Phone Number

• Verification & Validation of medical products and test report creation.• Verifying test data’s and document creation as per ISO 80369 and submitting to client.• Creating workflow for the testing team and managing day to day activities.• ISO 14971, CAPA creation/closing.• DHF – Change management, analysis and execution to current standards.• Testing of Intravascular devices and Diabetics care device – ISO 80369-7, Insulin pens, Swabs.• Decision Analysis and Resolution DAR for critical problems, document creation, solving and Execution and MSA Validation.• Test Protocol Review as per ISO guidelines and leading the team for project completion.• Fixture design development for testing samples as per standards- Creo.• Inspection Report creation for the product to be test.

• Submit corrective actions reports, Implementing IQ/OQ/PQ for the equipment’s. • Quality testing of pharma products as per standards – Capsules, Alcohol swabs and sanitizers related products.• ISO/IEC 17025 –Good laboratory practices.• Measurement system analysis for newly changed protocols & test methods of products.• Creating inventory records for the equipment’s and utilities, Job card creation and protocol verification as per standards.• Responsible for monitor process flow in the product development and testing plan as per deadline.• Verifying the final test report and submitting to the client.