Balasubikcha Sudhakaran

About Balasubikcha Sudhakaran

Validation and Compliance professional with 11+ years of experience in Computer System Validation (CSV) within the Life Sciences and Healthcare domain. Proven expertise in authoring, reviewing, and approving end-to-end validation deliverables, including Change Requests, Requirements Documents, Initial Risk Assessments, Validation Plans, Validation Protocols (OQ/PQ), RTM, STM, defect closure, and Validation Summary Reports (VSR).Extensive hands-on experience supporting regulated applications such as Post Market Quality Management (PQM), UDI Mobile, Oracle Argus Safety, and HP ALM. Highly proficient in HP ALM, JIRA, M-Files, along with ServiceNow and Veeva Vault QualityDocs (VQD) for validation and documentation management. Demonstrated experience working within compliance teams, performing end-to-end validation documentation review and approvals in alignment with client-specific SOPs and regulatory expectations.Strong knowledge of GxP, Good Documentation Practices (GDP), GAMP 5, 21 CFR Part 11, and EU Annex 11, with solid understanding of Change, Incident, Problem, Risk, and Defect Management processes. Well-versed in SDLC and STLC, with hands-on experience across V-Model, Agile, and Waterfall methodologies.Experienced in managing multiple projects and teams, collaborating with diverse global clients, and consistently delivering high-quality, compliant solutions. Holds an MBA in Project Management from Bharathiar University (2017) and is recognized for strong stakeholder communication, compliance leadership, and successful project execution.

Experience

1. Senior Validation Consultant

   EY

   Dec 2023 — Present

   Involved in preparation of end-to-end validation deliverables.*Regular touch base with business to discuss on the project status from compliance perspective.*Worked on analyzing the criticality of the system and prepared multiple interface agreements. Also worked on audit finding of a project.*Conducted briefing session on the User Requirements Specification (URS), Functional Specification (FS) and Design Specification (DS) processes in the ADO board.*Received multiple appreciation from business and clients.

Education

• VLB Janakiammal college of arts and science

  BCA, Computer Science

  2011 — 2014

• Bharathiar University

  MBA, Project Management