Job Description :
Role: Validation Lead
Location: Lexington, MA
Duration: Long Term

Need Passport Number and ID Proof for submission

Support validation activities for enterprise information systems of Shire. Primary responsibilities include maintenance of validated state of Shire’s GxP environments, and supporting implementation of new systems to the environment.
Facilitate the Computer System Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system.
Prepare computerized systems documentation such as but not limited to:
Validation Plan
CSV Risk Assessment
Test Plans and Test Summary Reports
Test Scripts, if required by collaborating with end users
Data Migration Plans/Reports
Traceability Matrix and Validation Summary Reports
Assess vendor provided validation packages and develop validation strategy by aligning it with Shire standards.
Assist in planning, implementing, and documenting user acceptance testing. Provide test execution training and assist team with the discrepancy resolution.
Ensure change controls, records, and procedures are in compliance with current GxP requirements.
Lead validation activities within a project or multiple global projects with medium to high complexity.
Create and manage the documents required for the development and validation of the computerized system and infrastructure.
Create and/or review all validation documents in the project.
Author/Review Validation Plan, Training Plan, Issues Log, Design Review, IQ Protocol/Report OQ Protocol/Report, PQ Protocol/Report, Test Cases, Test Incidents, Trace Matrix, Change Controls and Validation report.
Review and update/sign off on Functional Specifications, Design/Configuration Specifications, System Description and Training records.
Contribute to or gather CSV metrics for reporting purposes.
Coordinate and execute protocols. Executes the overall protocol process, including validation document creation, infrastructure test case creation/review and incident management, and status reporting.
Prepare documentation within a validation package per policy and procedure to support the validation of enterprise systems and infrastructure.
Review and approve the Qualification Protocol, test results, Test Incident Reports, Qualification Report.