Profile Details

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Hire Ajay K.

India

USD 20 /hr

11+ experience as Quality & Process Specialist | QA / UAT (Clinical Trials & Healthcare SaaS – eCOA, CDMS)

Profile Summary

Certifications :  ISTQB-BCS (CTFL) certified.  GCLP : Quality Management  ICH Good Clinical Practice E6 (R2)  RPA certification from Uipath academy.  Certified Scrum master eResearch Technology (ERT) GmbH, Germany (Clinical Trials) Project Summary: MasterScope® CT is the most advanced and complete centralized embedded systems application which is designed to capture the clinical trials data from Spirometry and AM3 devices. Designed specifically for clinical trials and the healthcare projects, the AM3® offer advanced technology for Asthma Monitoring. This comprehensive home spirometry measures and saves all relevant expiratory flow-volume parameters, such as PEF FEV1 and FVC. Responsibilities • Validating product following standards of FDA21CFR PART11 quality regulations. • Involved in embedded testing with different hardware and application. (ECG, ViaPad, Spirometry, AM Device, eCOA, Different Printers). • Involved in Test Planning, Test Documentations & Reviews for Software Verification & Validation. • Studied FRD’s, BRD’s and workflows to create test design documents. Preparing Test Requirement matrix, creating Test scripts. • Involved in daily defects triage calls with development team. • Reporting bugs against the test cases and mapping with requirements. • Preparing Exit criteria reports in the form of Test Execution and Defect Summary Report and lesson learn reports and sharing with the stakeholder. • Sprint planning and initiation scrum meetings

Subject Matter Expertise

• ★ Clinical Trials
• ★ Clinical Trial Documentation
• ★ Clinical Study Reports
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Safety Testing
• ☆ Regulatory Writing
• ☆ CMC Documentation

Services

• Writing
• Consulting

Writing Medical Writing

Consulting Regulatory Consulting

Work Experience

Quality & Process Specialist | QA / UAT (Clinical Trials & Healthcare SaaS – eCOA, CDMS)

Wipro (India)

April 2011 - Present

Education

MCA

IMT

June 2006 - July 2009

Certifications

• GCLP : Quality Management ( Credentials : d265572a-3e02-488e-abeb-94eae3b9b885)

  The Global Health Network

  August 2024 - Present

• ICH Good Clinical Practice E6 (R2) certified (Credential ID 1de01613-c7b3-448f-ade0-ee59895bf6cc)

  The Global Health Network

  August 2024 - Present

• Scrum Master Certified (SMC) (Credential ID xxxxxxxxxxxxxx)

  International Scrum Institute - Scrum Institute

  June 2022 - Present