Amir Singh

Senior Software Quality Engineer @Thermo Fisher Scientific

Chicago, IL, US

Represent Software Quality Assurance (SQA) in all Scrum-related activities, including sprint planning, reviews, retrospectives, release planning, and demos, ensuring quality is prioritized throughout each development cycle. Provide comprehensive support to software development and testing teams to uphold compliance across the Software Development Life Cycle (SDLC), addressing regulatory requirements and quality standards in all development phases, with a focus on cloud-native and cloud-hosted applications.Collaborate with development and commercial operations teams, delivering support for software validation packages, product monitoring, risk assessment, Corrective and Preventive Action (CAPA), and thorough investigation of quality issues, ensuring robust security and compliance in cloud-based infrastructures.Lead software verification and validation, ensuring compliance with QMS, ISO 27001, 21 CFR Part 11, Eudralex Annex 11, SOC 2, and GDPR. Define validation best practices for cloud-hosted applications, focusing on GxP, security risks, and data integrity.Drive continuous improvement in SDLC processes, working closely with cross-functional teams to enhance compliance, efficiency, and quality outcomes in software development, integrating cloud-native testing frameworks and automated validation tools.Oversee qualification of software vendors and service providers by ensuring their cloud-based solutions meet verification and validation requirements, maintaining high standards in all aspects of software quality while leveraging cloud governance and security best practices.Advocate for cloud-based quality assurance by leveraging AWS services such as AWS Lambda, Amazon RDS, AWS CodePipeline, and Amazon S3, along with Microsoft Azure and Azure DevOps, to enhance software testing, automation, and deployment processes in cloud and hybrid environments.

APJ Abdul Kalam Technological University

Bachelor's degree