Shiv Kumar Yadav

About Shiv Kumar Yadav

Currently working as an LS-Compliance Analyst at Cognizant, I bring hands-on experience…

Experience

1. Analyst - Ls Compliance

   Cognizant

   Jul 2025 — Present · Hyderabad, IN

   The Analyst – LS Compliance is responsible for supporting regulatory compliance and quality assurance activities in the Life Sciences domain. The role involves ensuring adherence to GxP (Good Laboratory/Clinical/Manufacturing Practices), data integrity, Computer System Validation (CSV), and industry regulatory requirements (such as US FDA, EMA, MHRA, etc.). This position also supports audits, CAPA tracking, and documentation for various regulated systems and processes in the pharmaceutical and biotech sectors-Key Responsibilities:Regulatory Compliance:Assist in monitoring and ensuring compliance with global regulatory standards like 21 CFR Part 11, Annex 11, and GAMP 5.Support implementation and maintenance of quality systems aligned with GxP guidelines.Computer System Validation (CSV):Prepare validation documentation (IQ, OQ, PQ, RTM, URS) for GxP-regulated systems.Coordinate testing, deviation tracking, and issue resolution during system qualification.Quality Documentation:Author and review SOPs, work instructions, and compliance documentation.Ensure proper document control and record retention in accordance with internal and regulatory standards.Audit & Inspection Support:Support internal and external audits by preparing documentation, evidence, and audit trails.Follow-up on audit observations, and assist in root cause analysis and CAPA implementation.Risk Management:Participate in risk assessments for IT systems, vendors, and operational processes.Help in evaluating control measures to mitigate compliance risks.

Education

• Veer Bahadur Singh Purvanchal University, Jaunpur

  Master in science

  2019 — 2021