Validation Analyst

Job Title: Validation Analyst (HP ALM / Micro Focus ALM)

Experience: 4–5 Years

Location: [Hyderabad / Remote / Hybrid]

Shift: Overlap with US EST (minimum post-noon IST)

Job Summary

We are seeking a detail-oriented Validation Analyst with hands-on experience in HP ALM / Micro Focus (OpenText) ALM to support requirements management, traceability, and validation activities within a GxP-regulated environment. The ideal candidate will have strong expertise in the Requirements module, along with a working understanding of testing processes and CAPA/defect management.

Key Responsibilities

• Manage and maintain requirements within the ALM Requirements module
• Perform requirement lifecycle activities including:
• Routing, approvals, revisions/versioning, and obsoletion
• Ensure end-to-end traceability across validation deliverables
• Support risk assessments and risk-based requirement mapping
• Create, review, and maintain Traceability Matrices (RTM/TM)
• Generate and review validation documentation:
• URS (User Requirements Specification)
• FS (Functional Specification)
• DS (Design Specification)
• Map requirements across validation artifacts and deliverables
• Collaborate with testing teams to track execution progress using:
• Test Plan
• Test Lab
• Defect Management modules
• Support CAPA / defect management processes
• Independently track progress and contribute to TM/RTM reviews
• Ensure compliance with CSV / CSA validation lifecycle standards
• Work closely with global stakeholders and cross-functional teams

Required Skills & Qualifications

• 4–5 years of hands-on experience in HP ALM / Micro Focus / OpenText ALM
• Strong expertise in the Requirements module
• Proven experience in:
• Requirement lifecycle management
• Traceability and documentation
• Good understanding of:
• ALM Test module (Test Plan, Test Lab, Defects)
• CAPA / defect management processes
• Experience working in a GxP-regulated environment
• Solid knowledge of CSV / CSA validation lifecycle
• Strong documentation, review, and analytical skills
• High attention to detail and ability to work independently
• Experience working with global teams and stakeholders

Nice to Have

• Experience with other QMS tools
• Exposure to regulated industries such as Pharma, Life Sciences, or Healthcare

Work Requirements

• Willingness to work in overlapping hours with US EST time zone
• Ability to manage deliverables independently in a fast-paced environment