Sathya Narayanan, Csm®
About Sathya Narayanan, Csm®
Sathya Narayanan, Csm®, is a Senior Computer System Validation Engineer at Bristol-Myers Squibb in County Dublin, Ireland, with extensive experience in software validation and quality assurance across various industries.
Current Position at Bristol-Myers Squibb
Sathya Narayanan is currently serving as a Senior Computer System Validation Engineer at Bristol-Myers Squibb. Based in County Dublin, Ireland, his role involves validating protocols and ensuring compliance with regulatory standards such as FDA 21 CFR Part 11 and EU Annex 11. His expertise in ISO standards, including ISO 13485 for Quality Management and ISO 14971 for risk management, contributes to the company's adherence to rigorous quality and risk management practices.
Previous Experience at M800 Limited
From 2017 to 2019, Sathya Narayanan worked at M800 Limited in Kowloon, Hong Kong, as a Scrum Master and Validation QA Engineer. During his tenure, he utilized both Agile (Scrum) and waterfall methodologies to develop and maintain test scripts based on business and functional requirements. His role also involved training, mentoring, and motivating new graduates and team members.
Career Development at HSBC
Sathya Narayanan served as a Senior Functional Test Engineer (Murex Specialist), Scrum Master, Business Analyst, and UAT at HSBC from 2016 to 2017 in Guangzhou, Guangdong, China. His responsibilities included collaborating with business partners and agile teams to define, coordinate, and execute User Acceptance Testing. He also played a key role in developing process flows in consultation with business and process teams.
Educational Background
Sathya Narayanan holds a Bachelor's Degree in Information Technology from Anna University, where he studied from 2007 to 2011. Prior to that, he completed his Higher Secondary education in Computer Science at A V Higher Secondary School from 2005 to 2007. His strong educational background laid the foundation for his extensive career in software testing and validation.
ISO and Regulatory Compliance Expertise
Sathya Narayanan has a robust understanding of ISO standards, particularly ISO 13485 for Quality Management and ISO 14971 for risk management. He has developed test environments, set up test platforms for products or systems, and created and executed Master Validation plans and protocols. Additionally, he has maintained validation packages to meet GxP standards and FDA 21 CFR Part 11 compliance along with GAMP5. His work often involves performing risk assessments and supporting regulatory and customer audits to ensure documentation and practices meet quality standards and company policies.