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Validation Analyst

2-3 years
₹8 – ₹11 LPA
10 July 31, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ B.Tech/ M.Tech/ BE/ ME Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Validation Analyst – Sitero – Bangalore (Full-Time)
Location: Bangalore, Karnataka
Department: Validation Services
Employment Type: Full-Time


Company Overview:
Sitero is a fast-growing clinical services and software solutions company supporting the life sciences industry. We offer technology-enabled services that enhance the efficiency and integrity of clinical trials across a wide range of therapeutic areas, with a focus on ethics, compliance, and innovation.


Position Summary:
As a Validation Analyst, you will be responsible for planning, executing, and documenting validation efforts for software systems and integrations, especially in FDA-regulated environments. You will work on validating both traditional and AI-driven software, ensuring compliance with industry standards such as FDA 21 CFR Part 11 and GxP.


Key Responsibilities:

  • Plan and execute software validation activities (off-the-shelf and custom integrations).

  • Perform end-to-end validation using tools like Postman and SOAP UI.

  • Validate AI-driven software to ensure accuracy, performance, and regulatory compliance.

  • Develop validation protocols including IQ, OQ, PQ, test cases, and traceability matrices.

  • Use Azure DevOps for test case management and documentation.

  • Ensure validation in cloud-hosted environments meets compliance standards.

  • Conduct system risk assessments and implement risk mitigation strategies.

  • Ensure alignment with FDA 21 CFR Part 11, GxP, and industry best practices.

  • Collaborate across Software Development, QA, Regulatory Affairs, and IT teams.

  • Produce thorough validation reports for internal/external audits.

  • Mentor junior analysts and promote best practices in validation processes.


Qualifications & Experience:

  • Bachelor’s degree in Computer Science, Engineering, or related technical field.

  • 2–3 years of experience in API testing, integration validation, and AI solution workflows.

  • Proficient in Postman, SOAP UI, and Azure DevOps.

  • Experience in cloud software validation (IaaS, PaaS, SaaS).

  • Solid understanding of SDLC, Agile, Scrum, and SAFe validation processes.

  • Familiarity with regulatory standards: FDA 21 CFR Part 11, GxP.

  • Strong communication skills and collaborative mindset.


Preferred Skills:

  • Experience with CI/CD pipelines.

  • Familiarity with database validation and data migration.

  • API testing expertise.


Estimated Salary: ₹8 – ₹11 LPA (based on experience)