Tridev Sudhakar
About Tridev Sudhakar
Tridev Sudhakar is a Validation Engineer with extensive experience in the pharmaceutical industry, having worked for several companies including Ligand Pharmaceuticals and Nektar Therapeutics. He specializes in validating SaaS/PaaS applications and has a strong background in developing test scripts and managing change control processes.
Work at Nektar Therapeutics
Tridev Sudhakar has been employed at Nektar Therapeutics as a Validation Engineer since 2023. His role involves ensuring compliance and validation processes within the organization. He works on-site in California, United States, contributing to the company's commitment to quality and regulatory standards in the pharmaceutical industry.
Previous Experience in Pharmaceutical Validation
Tridev Sudhakar has a diverse background in validation engineering within the pharmaceutical sector. He worked at Ligand Pharmaceuticals from 2021 to 2023, and prior to that, he held positions at Hetero Drugs Limited in 2016, Aurobindo Pharma Ltd from 2017 to 2018, and Lupin India in 2019. His experience spans various aspects of validation, including the implementation of quality systems and compliance with regulatory requirements.
Education and Expertise
Tridev Sudhakar holds a Bachelor of Engineering degree in Mechanical Engineering from PES University. He completed his secondary education at India International School and furthered his studies at Sri Bhagawan Mahaveer Jain College, achieving a 12th CBCS in PCMC. His educational background supports his expertise in validation processes and quality assurance in the pharmaceutical industry.
Validation Skills and Knowledge
Tridev Sudhakar demonstrates strong expertise in the validation of SaaS/PaaS applications, particularly Veeva applications. He is skilled in developing and executing test scripts, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). His knowledge extends to analytical instrument validation, including HPLC, GC, GCMS, and ICP-MS, and he possesses a thorough understanding of software development life cycle methodologies such as Waterfall, GAMP V, and Agile.
Regulatory Compliance and Quality Systems
Tridev Sudhakar has extensive knowledge of regulatory compliance, including GAMP, GxP, and ERES regulations, specifically 21-CFR Part 11. He is experienced in managing change control processes and has authored and developed Standard Operating Procedures (SOPs) in the pharmaceutical industry. His competencies in quality systems and standards, including 21 CFR parts 11, 50, 58, 210, and 211, contribute to his effectiveness in enhancing compliance results.