Senior Software Tester-I

Roles & Responsibilities

• Perform end-to-end validation testing activities for GxP applications in compliance with regulatory requirements.
• Develop, review, and execute validation deliverables including: o Validation Plans o Test Strategy & Test Plans o IQ/OQ/PQ protocols o Test Scripts o Traceability Matrix (RTM) o Validation Summary Reports
• Conduct functional, integration, regression, and user acceptance testing for validated systems.
• Ensure applications comply with applicable GxP, CSV, and regulatory standards.
• Review business requirements, functional specifications, and technical documents to identify test scenarios.
• Execute manual validation test cases and document results with appropriate objective evidence.
• Perform defect management including identification, documentation, tracking, retesting, and closure.
• Support change control, impact assessments, risk assessments, and periodic review activities.
• Collaborate with business users, QA, development teams, and validation stakeholders.
• Maintain validation documentation according to SOPs and quality processes.
• Support audits and regulatory inspections by ensuring complete and compliant validation evidence.

Mandatory Skills

• Minimum 5+ years of experience as a Validation/Test Engineer.
• Hands-on experience working in a GxP-regulated environment is mandatory.
• Strong knowledge of: o Computer System Validation (CSV) o GAMP 5 guidelines o FDA 21 CFR Part 11 compliance o ALCOA+ principles o Data Integrity requirements
• Experience in preparing and executing IQ, OQ, and PQ validation documentation.
• Strong understanding of SDLC and validation lifecycle processes.
• Experience with test management and defect tracking tools.

Technical Skills

• Test Management Tools: ALM/QC, Jira, Azure DevOps, or equivalent
• Documentation & Validation Tools: Veeva, TrackWise, ServiceNow, or similar (preferred)
• Database/SQL knowledge preferred
• Understanding of Agile and Waterfall delivery methodologies Preferred Qualifications
• Experience in pharmaceutical, biotech, clinical, laboratory, or life sciences domains.
• Experience validating applications in Life Sciences domain
• Exposure to automated testing tools is an advantage.
• Knowledge of cloud-based validated systems preferred.

Soft Skills

• Excellent analytical and problem-solving skills.
• Strong attention to detail and documentation quality.
• Good communication skills with experience interacting with global stakeholders.
• Ability to work independently in a regulated environment.

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