Lead I - Software Testing

UST; Chennai District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

UST in Chennai is seeking a Validation Engineer with 5-8 years of experience to support validation activities for regulated systems and applications within the Life Sciences and Clinical Research domain.

You will execute validation activities for applications, systems, and business processes; create and maintain validation plans, protocols, reports, and traceability matrices; perform risk assessments for system changes; and collaborate with cross-functional teams to ensure compliance and quality

Qualifications

• Experience in Computer System Validation (CSV), Software Validation, or Quality Assurance.
• Strong understanding of Validation Lifecycle, SDLC, STLC, IQ, OQ, PQ, URS, and RTM.
• Knowledge of GxP, 21 CFR Part 11, Annex 11, and regulatory compliance requirements.
• Experience in preparing and executing validation protocols, test scripts, and validation documentation.

Responsibilities

• Execute validation activities for applications, systems, and business processes.
• Create and maintain validation plans, protocols, reports, and traceability matrices.
• Perform risk assessments and impact analyses for system changes.
• Support system implementations, enhancements, and upgrades.
• Collaborate with cross-functional teams to ensure compliance and quality standards.
• Support audit and inspection readiness activities.

Skills

Analytical thinking

Troubleshooting

Documentation

Tools

Jira

ALM

Azure DevOps

Job description

Job Summary

Hiring: Validation Engineer. We are looking for a Validation Engineer with 5-8 years of experience to join our team and support validation activities for regulated systems and applications within the Life Sciences and Clinical Research domain.

Responsibilities

• Execute validation activities for applications, systems, and business processes.
• Create and maintain validation plans, protocols, reports, and traceability matrices.
• Perform risk assessments and impact analyses for system changes.
• Support system implementations, enhancements, and upgrades.
• Collaborate with cross-functional teams to ensure compliance and quality standards.
• Support audit and inspection readiness activities.

Requirements

• Experience in Computer System Validation (CSV), Software Validation, or Quality Assurance.
• Strong understanding of Validation Lifecycle, SDLC, STLC, IQ, OQ, PQ, URS, and RTM.
• Knowledge of GxP, 21 CFR Part 11, Annex 11, and regulatory compliance requirements.
• Experience in preparing and executing validation protocols, test scripts, and validation documentation.
• Familiarity with tools such as Jira, ALM, or Azure DevOps.
• Strong analytical, troubleshooting, and documentation skills.

Preferred Qualifications

• Experience in Life Sciences, Clinical Research, Pharmaceutical, or Healthcare domains.
• Exposure to SaaS platforms and cloud-based systems.
• Understanding of Agile methodologies and regulatory compliance frameworks.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.