spectraforce.com
Raleigh, NC
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Job Description :
Job Title: IT Validation Lead
Duration: 12 Months
Location: Round Lake (60073)
Team provides compliance oversight and validation services for global IT Supports GLP / GMP / GCP
Looking for validation practices helping the team when they are finalizing their specification documents when they are routing their documents through the validation system, approving test cases, helping facilitate testing defects, writing summary reports during the validation process.
Understanding of testing, must have good communication skills, must be proficient in word
Experience in HPLM is a big plus and Siemens TCU for document management and routing.
Looking to move into AWS for infrastructure, if anyone has any experience with infrastructure as a service.
Used to good documentation practices and are used to the stringency of the space and understand what validation is.
Validation leads dealing with different GMP protocol
Work with a large IT project team(s) to define Validation requirements and documentation to be used for Application/System qualification. Responsible for creating the documents required for the development and validation of the computerized system.
Prepares documentation within a validation package per policy and procedure to support the validation of enterprise systems and IT infrastructure.
Creates the Validation Plan, Qualification Plan, Qualification report(s) Final validation report, Trace Matrix, System Description, Data Migration Plan
Coordinates the preparation and routes the following validation documents: Risk Management Report, User Requirements Specification, Functional Specification, Configuration Specification, Design Specification, and Data Migration Specification.
Completes final document processing to release validation documents within the document management system.
Coordinates and executes validation plans – executes the overall protocol process, including test case creation/approval, test case execution reviews, test incident management, and status reporting
Coaches third party testers on good testing and documentation practices.
Understands and follow appropriate Software Development Life Cycle (SDLC) quality validation processes. Excellent technical writing skills, attention to detail, Strong Communication Skills, Good Project Management Skills, proficient in MS word, experience in HP ALM a plus.
             

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