- Develop and manage Validation Master Plans (VMPs) and Validation Plans (VPs) for software systems in regulated environments.

- Lead validation for Oracle Agile PLM, ensuring compliance with FDA standards and internal quality requirements.

- Create and execute Design Change Plans (DCPs) for system updates and modifications.

- Validate non-product systems including Quality Management Systems (QMS), **ERP platforms, and electronic documentation tools.

- Design and perform automated and manual testing using tools like Selenium, Postman, TestNG, and Robot Framework.

- Conduct software risk assessments and determine validation scope in collaboration with QA and regulatory teams.

- Maintain traceability matrices to ensure requirements are properly tested and documented.

- Create and update validation documentation including URS, FRS, CS, VSR, and system lifecycle records.

- Support design reviews, configuration management, and change control processes.

- Coordinate with IT, QA, Regulatory Affairs, and business stakeholders to ensure validation alignment.

- Track issues and manage defects using tools like JIRA, Azure DevOps, or Bugzilla.

- Integrate testing into CI/CD pipelines using Jenkins, GitLab CI, or Azure Pipelines.

- Ensure systems meet FDA 21 CFR Part 11 requirements for audit trails, e-signatures, and data integrity.

- Perform CAPA investigations, document root causes, and develop corrective action plans.

- Lead and support User Acceptance Testing (UAT) and end-to-end integration testing.

- Conduct periodic reviews and revalidation following system upgrades or regulatory changes.

- Prepare documentation and artifacts for internal/external audits.

- Develop training materials, SOPs, and user guides for validated systems.