Sr. Validation Analyst

We are seeking a Validation Analyst with hands-on experience in HP ALM / Micro Focus/Open Text ALM, supporting requirements management, traceability, and validation activities in a GxP-regulated environment. The role requires strong expertise in the Requirements module, along with a working understanding of testing and CAPA processes.

We need 4-5 years of experience.

Notice preferred - Immediate - 30 days.

Nice to Have - Other QMS tools experience too

45 years of experience in HP ALM / Micro Focus ALM

Strong hands-on experience in the ALM Requirements module

Experience in requirement routing, approvals, revisions/versioning, and obsoletion

Ability to manage requirement lifecycle and maintain traceability

Support risk assessments and risk-based mapping of requirements

Experience in generating and reviewing Traceability Matrices (RTM/TM)

Ability to generate and review requirement reports (URS, FS, DS)

Experience in mapping requirements across validation deliverables

Good understanding of ALM Test module (Test Plan, Test Lab and Defect Management) for tracking execution and progress

Basic understanding of CAPA / defect management module

Ability to independently track progress and support TM/RTM reviews

Good understanding of CSV / CSA validation lifecycle

Experience working in a GxP-regulated environment

Strong documentation, review, and attention to detail

Ability to work independently and manage deliverables

Willingness to support US EST hours (at least until post-noon IST)

Experience working with global teams and stakeholders