Mohanasri Rajaram - IT Validation Associate Manager

Dublin, Ireland

Experience

Mar 2025 - Present

11 months

IT Validation Associate Manager

Viatris

Led a site-wide GxP CSV initiative by conducting risk-based assessments of over 500 manufacturing and laboratory systems, ensuring 100% compliance with SDLC and IT Quality Management System (ITQMS) and regulatory standards
Executed end-to-end validation activities for over 20 manufacturing and laboratory systems by authoring and executing IQ, OQ, and PQ protocols for various departments like Production, QC, Packaging and Engineering, ensuring strict alignment with site ITQMS and industry best practices
Spearheaded site-wide remediation efforts, updating the ITQMS to align with global policies and leading to a 100% compliance rate across the organization
Empowered cross-functional teams by training over 50 team members on CSV-related activities, which brought the entire site to full compliance ahead of schedule. Proactively identified and mitigated risks on existing validated systems by raising CAPAs, Change Controls in TWS and performing comprehensive risk assessments that addressed 100% of identified gaps
Boosted project efficiency and productivity by 30% by meticulously adhering to strict project timelines and streamlining validation processes. Secured data integrity by identifying gaps in over 30 critical spreadsheets, remediating them according to global policies, and achieving validated status by aiding various departments with the deviations and the IRs that were recorded
Collaborated with cross-functional teams (Manufacturing, Quality, IT) to train over 50 members on CSV procedures, proactively mitigating compliance risks and achieving full site-wide compliance ahead of schedule
Demonstrated expertise in regulatory compliance by working closely with Quality Assurance and Technical Transfer teams to implement effective change control plans and root cause analysis (FMEA, HCCP, Fishbone analysis) for non-conformities

Nov 2020 - Jun 2023

2 years 8 months

Chennai, India

Project Associate

Easy Solutions

Served as a lead digital validation consultant for multiple pharma companies focusing on 21 CFR Part 11, EU Annex 11, GAMP5, GMP, and GDPR compliance to ensure all SLDC deliverables of the clients are met (from software installation to business release)
Developed and reviewed validation strategies for computerized systems, ensuring compliance with regulatory requirements and audit readiness while implementing CAPA plans and supporting clients with the end-to-end process of IQ, OQ and PQ
Drafted and executed hands-on validation documentation, including Validation Plans, Requirements Specifications (URS/FS/DS), and IQ/OQ/PQ protocols, while streamlining processes by 25% to improve project traceability and efficiency
Facilitated seamless data installation and migration for clients, ensuring 100% accuracy throughout the process
Ensured cleaning of client data and spearheaded successful integration of services into clients’ digital infrastructure with no technical issues and meticulously reviewed validation documents to comply with cGMP, ICH, and FDA regulations
Collaborated with cross-functional project, sales, technical (development and SQA/testing), and executive teams using project management tools such as Atlassian JIRA, Confluence, SharePoint, and LucidChart, enhancing overall service delivery to 100%
Worked closely with quality assurance and quality control teams in the pharmaceutical industry, implementing change control plans, performing risk assessment (FMEA, HCCP, Fishbone analysis), and analysing root causes of non-conformities to ensure complete regulatory compliance
Led a team of 5 through planning, execution, and monitoring of various project stages
Successfully transitioned 10+ pharmaceutical sites to digital platforms, reducing management costs by $250,000 and maintaining rigorous regulatory standards for cleaning validation

Summary

Highly accomplished Computer Systems Validation (CSV) Engineer with nearly 4 years of experience in leading and executing GxP CSV projects for Life Sciences and Healthcare clients. Expertise in ensuring regulatory compliance with cGMP, 21 CFR Part 11, GAMP5, Proven success in managing complex projects, leading cross-functional teams and driving digital transformation initiatives. Skilled in risk assessment, validation documentation, and streamlining processes to deliver high-quality, compliant solutions.

Skills

Communication Skills: Oral, Written And Presentation Skills.
Tools: Tableau, Ms Word, Ms Excel, Powerpoint, Atlassian Jira, Confluence.
Hard Skills: Sdlc, Urs, Frs, Iq/oq/pq, Validation Plan And Report, Gap Assessments, Risk Assessments And Analysis, Fmea, Tws, Capa Management, Ir, Cgmp, Sop’s, Lean Six Sigma, 21 Cfr Part 11, Eu Annex 11, Gdpr, Regulatory Consulting, Project Management, Html And Javascript (Basics), Agile And Waterfall Management Methodologies.
Soft Skills: Collaborative, Leadership, Solution Oriented, Team Player, Strategic & Critical Thinking, Attention To Detail.

Languages

Tamil

Native

English

Elementary

Education

Sep 2023 - Sep 2024

University College Dublin

MSc Biotechnology and Business · Biotechnology and Business · Dublin, Ireland

Feb 2020 - Jul 2020

University of Massachusetts

Student Exchange · Amherst, United States

Aug 2016 - Aug 2020

SASTRA Deemed University

B.Tech Bioengineering · Bioengineering · India

Certifications & licenses

Six Sigma Green Belt

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Experience

IT Validation Associate Manager

Viatris

Project Associate

Easy Solutions

Summary

Skills

Languages

Education

University College Dublin

MSc Biotechnology and Business · Biotechnology and Business · Dublin, Ireland

University of Massachusetts

Student Exchange · Amherst, United States

SASTRA Deemed University

B.Tech Bioengineering · Bioengineering · India

Certifications & licenses

Six Sigma Green Belt

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