Sr. Validation Analyst
Compliance Group Inc
Job Description
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 4โ5 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