IT QA CSV Consultant

Regulatory Hatboro, Pennsylvania United States


This position is responsible to Lead/ participate in NOE, EOE and CAPA; initiation, investigation, coordination and closure.

Own and manage the IT deviation process which includes providing organizational visibility to the deviation during its lifecycle.

Identify the type of deviation, tracking its progress, and resolve deviation activities.

Document the event causing the deviation, conducting an investigation, identifying and documenting root cause, and managing the CAPA process

Act as a Sr. ITQA Validation Specialist on IT Infrastructure Qualification projects
Author the typical validation and testing documentation for IT infrastructure validation initiatives such as validation plans, summary reports requirements, specifications, trace matrix, qualification protocols and test scripts, testing defects, etc.

Lead and coordinate the infrastructure testing efforts such as evaluating testing needs, data integrity risks/ mitigations, coordinating testing activities and issue resolution, as directed
Participate in Change Management required for IT infrastructure
Execute any other activities relevant to IT Quality Assurance, as directed by Clients management
training, COD, laboratory services, and solutions they need to remain innovative and competitive.