IT Infrastructure Qualification Lead

Role: IT Infrastructure Qualification Lead Location: Sleepy Hollow, NYScope of Job:The ITIQ is responsible for the day-to-day authorizing and reviewing execution of IT Infrastructure Qualification (ITIQ) activities. Work with the broader QA Validation and IT Teams to ensure IT infrastructure qualification deliverables are completed per schedule.Primary Responsibilities:

• Function as the IT Infrastructure Qualification (ITIQ) Lead on the company ITIQ projects, take ownership of related tasks, work under minimal supervision, utilize industry experience and best judgement to make tactical decisions.
• Author the typical IT Infrastructure Qualifications deliverables such as Initial IT Infrastructure Assessments, Qualification Project Plans Summaries, Test Plan Summaries, Platform Requirement Specification with subsequent Functional Risk Assessments, Design Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ) and scripts, testing defects, etc.
• Support the development of IT Administrative SOPs for the infrastructure component platforms', with IT QA and IT Teams
• Oversee and coordinate the infrastructure component platform test execution efforts.
• Support IT department personnel in navigating through and participating in the GxP Document Management Process (EDMS, Qumas, Doc Compliance) including coordinating workflow approvals.
• Support the refinement implementation of the IT Infrastructure Qualification Programs
• Support IT department in navigating through and participating in the GxP Change Control Process (including support review of test plans)