Bharanitharan Rajendran
About Bharanitharan Rajendran
Bharanitharan Rajendran serves as the Senior Quality Manager (CSV) at TFS - Clinical Contract Research Organization in Munich, Bavaria, where he has worked since 2020. He has extensive experience in Computer System Validation across various organizations, including Novartis and Infosys Consulting, and holds a Master of Science in Avionics.
Work at TFS HealthScience
Bharanitharan Rajendran has been serving as the Senior Quality Manager (CSV) at TFS HealthScience since 2020. In this role, he manages and leads all aspects of Computer System Validation (CSV) within the organization. His responsibilities include overseeing system inventory, validation, risk management, test management, change control, and IT compliance. He actively contributes to the development and improvement of the TFS Quality Management System (QMS) in the areas of CSV and IT. Additionally, he prepares and supports operational staff for customer audits and regulatory inspections, acting as a Quality Lead auditor when necessary.
Previous Experience in Quality Management
Prior to his current position, Bharanitharan Rajendran held several roles in quality management. He worked at Novartis as a Project Quality Manager (CSV) from 2016 to 2020, and at Infosys Consulting as a Consultant (Quality Manager - CSV) during the same period. His earlier experience includes a role as Senior Software Engineer (Validation Manager - CSV) at IGATE Global Solutions from 2011 to 2015 and as a Senior Compliance Analyst (CSV) at ArisGlobal for one year. His extensive background in CSV has equipped him with the skills necessary to manage quality issues and address process deviations effectively.
Education and Expertise
Bharanitharan Rajendran is pursuing a Master of Science (MS) in Avionics at the International Institute for Aerospace Engineering & Management, a program he has been enrolled in since 2014. He holds a Bachelor of Engineering (B.E.) in Computer Science & Engineering from SRR Engineering College, Chennai, which he completed from 2006 to 2010. His foundational education includes studies in Maths-Biology and Maths-Science at Nalanda Matric Hr. Sec. School and Swami Vivekananda Matriculation Higher Secondary School, respectively. He is also a certified Internal ISO27001 Auditor, demonstrating his expertise in implementing Information Security Management Systems.
Achievements in Computer System Validation
Bharanitharan Rajendran has developed and implemented a comprehensive Computer System Validation (CSV) framework that aligns with various industry standards, including 21 CFR Part 11, EU Annex 11, ICH E6, ICH Q9, GAMP5, and ISPE GPGs. He has established robust Business Continuity and Disaster Recovery measures for organizations and performs software vendor qualification audits to ensure compliance with Good Practice (GxP) and Business Critical systems. His experience includes preparing, conducting, and following up on internal and external CSV audits, which encompass system/process audits and vendor audits.
Leadership and Mentorship
In his professional journey, Bharanitharan Rajendran has guided teams from inception to becoming reliable CSV consultants through coaching and mentoring. He has a demonstrated ability to manage quality issues, address process deviations, and assess data protection related to GDPR. His leadership skills are evident in his management of quality aspects within TFS, where he plays a crucial role in fostering a culture of quality and compliance across the organization.