Validation Analyst

Compliance Group Inc; Hyderabad; Sur place; INR 800 000 - 1 200 000; Plein temps

Résumé du poste

A leading compliance services firm seeks a detail-oriented Validation Analyst in Hyderabad, India. Your role will involve managing requirements within the ALM Requirements module and ensuring end-to-end traceability across validation deliverables. We require 4–5 years of hands-on experience in HP ALM and strong documentation skills. Ideal candidates have experience in a GxP-regulated environment and the ability to work independently. Flexibility for overlapping hours with US EST is essential for this position.

Qualifications

• 4–5 years of hands-on experience in HP ALM / Micro Focus / OpenText ALM.
• Experience in a GxP-regulated environment.
• Solid knowledge of CSV / CSA validation lifecycle.
• Strong documentation, review, and analytical skills.

Responsabilités

• Manage and maintain requirements within the ALM Requirements module.
• Ensure end-to-end traceability across validation deliverables.
• Support risk assessments and risk-based requirement mapping.
• Generate and review validation documentation.

Connaissances

HP ALM / Micro Focus / OpenText ALM

Requirements module expertise

Traceability

Documentation skills

Attention to detail

Outils

QMS tools

Description du poste

Experience: 4–5 Years

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
• 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
• Traceability and documentation
• Good understanding of:
• 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