Shiva Prasath. P

Dynamic and detail-oriented Validation & Test Engineer with 3+ years of experience in the pharmaceutical and life sciences domain, specializing in GxP-compliant Computer System Validation (CSV), process validation, and cleaning validation. Proven expertise in authoring, executing, and reviewing end-to-end validation documentation in alignment with FDA (21 CFR Part 11), EMA, and ICH guidelines. Strong exposure to global regulatory audits and extensive hands-on experience with Oracle Argus (pharmacovigilance) and TrackWise (QMS).

Known for cross-functional leadership, audit readiness, and delivering high-quality compliance outcomes for major pharma clients including Cipla, USV, Glenmark, Alkem, and Zydus.

Senior Test Engineer - HCL Technologies - Chennai

(2024-07)

• Authored and executed validation deliverables including Validation Plans, Functional Risk Assessments (FRA), OQ/PQ protocols, Requirement Traceability Matrices (RTM), and Validation Summary Reports (VSR).
• Led deviation management, change controls, root cause analysis, and CAPA implementation, ensuring improved compliance and audit readiness.
• Supported creation of EMA and US FDA safety reports in Oracle Argus, strengthening global regulatory compliance.
• Reviewed and approved URS, FRS, and SRS documents for comprehensive traceability.
• Conducted manual and API testing (REST & GraphQL), ensuring end-to-end system validation.

Validation Trainee - Navitas Life Sciences - Chennai

(2022-12 - 2024-05)

• Executed process and cleaning validation protocols, supporting successful regulatory inspections for top pharma clients.
• Prepared and reviewed validation documentation including Validation Plans, Qualification Summary Reports, and Traceability Matrices.
• Collaborated in deviation handling, risk assessments, and periodic review activities, ensuring lifecycle compliance.
• Validated and maintained QMS in TrackWise, improving documentation control and audit trail integrity.
• Actively participated in internal and external audits, contributing to smooth inspection outcomes.

B.E. - Mechanical Engineering - Jeppiaar Engineering College (2022)

HSC - Gill Adarsh Matriculation Higher Secondary School (2018)

SSLC - St. Bede's Anglo Indian Higher Secondary School (2016)