Saikarthik Gunti

About Saikarthik Gunti

I am an accomplished professional with extensive experience in Computer System Validation (CSV) and Quality Assurance (QA) leadership within the pharmaceutical and medical device industries. With a proven track record of ensuring compliance with regulatory requirements, I excel in designing and executing validation protocols, managing QA processes, and leading cross-functional teams to achieve operational excellence.My expertise includes- Spearheading CSV activities throughout the lifecycle of computer systems, ensuring adherence to GxP guidelines and regulatory standards- Developing and implementing robust validation strategies that enhance product quality and data integrity- Managing QA programs to uphold stringent quality standards and drive continuous improvement initiatives- Collaborating effectively with stakeholders at all levels to achieve organizational objectives and ensure regulatory compliance.I bring a strong commitment to excellence, a meticulous attention to detail, and a passion for maintaining the highest standards of quality and compliance in every aspect of my work. With my background in CSV and QA leadership, I am dedicated to contributing to the success and growth of innovative healthcare organizations.I possess a robust educational foundation in business administration, energy management and Mechanical Engineering, having earned a Master of Business Administration from the University of the Cumberlands and a Master\'s degree in Energy Management and Systems Technology from New York Institute of Technology and Bachelor\'s degree in Mechanical Engineering from JNTU, Hyderabad. Additionally, I hold several certifications including Lean Six Sigma - White Belt, Lean Management, ISO Management System Audit Techniques and Best Practices, and Certified Associate in Project Management.Driven by a passion for mastering new technologies, I am actively enhancing my expertise in software validation, system integration testing, and user acceptance testing. My career objective is to leverage my skills in validation and quality assurance to foster innovation and uphold excellence within the healthcare sector.This summary showcases my expertise and highlights my value as a CSV and QA leader, making me a valuable addition to any team dedicated to advancing quality and regulatory excellence in the medical industry.

Experience

1. Software Quality Senior Engineer

   Flex

   Jun 2024 — Present · Austin, TX, US

Education

• New York Institute of Technology

  Master's degree

  2015 — 2016

• Vaagdevi College of Engineering

  Bachelor's degree

  2010 — 2014

• University of the Cumberlands

  Master of Business Administration - MBA

  2019 — 2020