Ashokkumar Nagarajan

Computer System Validation & Data Integrity Specialist @Piramal Pharma Solutions

Newcastle upon Tyne, GB

At an end-to-end CDMO facility, responsible for overseeing Computerised System Validation (CSV) across the entire site, including development, API production, and finished product manufacturing. Key responsibilities include:Leading Computer System Validation (CSV) activities at the site, supporting the validation of new equipment and QC instrument commissioning, and reviewing validation deliverables and documentation.Conducting routine periodic reviews of equipment and computer systems to ensure alignment with current regulatory and industry standards.Evaluating vendors for new and existing computer systems as part of the vendor assurance process to ensure compliance and reliability.Managing the validation of new and existing computer systems throughout their lifecycle, approving associated deliverables such as Validation Plans, Summary Reports, Test Plans, Test Reports, System/User Acceptance Test Cases, and Risk Assessments.Acting as a Quality Compliance Authority for all computerized systems validation activities, ensuring regulatory compliance and providing quality oversight throughout project phases.Performing site-wide audits and critical system reviews to identify and address abnormal activities or compliance gaps.Successfully led a CapEx project, overseeing the commissioning of a packaging line from initiation to completion, including serialization and aggregation processes.Conducting comprehensive Data Integrity assessments across site equipment and systems to ensure compliance with GAMP regulations and industry standards

Kongu Engineering College

Diploma of Education

SRM University

Bachelor of Technology (B.Tech.)