Job Title: Validation Analyst (HP ALM / Micro Focus ALM)
Experience: 45 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
- 45 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
