Description

Manage validation, risk analysis, and compliance activities for enterprise applications and quality systems.

Responsibilities

• Review and approve validation test scripts, incident reports, and validation protocols.
• Execute change control activities for system enhancements, defect fixes, and data migration.
• Implement GxP requirements (GMP, GDP, GLP, GCP) into existing systems.
• Coordinate with cross-functional teams to complete validation deliverables according to project schedules.
• Manage system decommissioning by overseeing data migration and archival from legacy systems.

Required Skills

• 3+ years of experience in software development or validation roles.
• Experience with Data Migration and Data Migration Planning.
• Proficiency in ALM and HP ALM.
• Hands-on experience with ServiceNow and DocuSign.
• Competency in SharePoint and Office 365.
• Experience using Workday and Medidata RCM.
• Knowledge of LIMS.
• Ability to work with User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
• Experience managing Deviation Logs and Testing Summary Reports.

Key Skills

Education

Any Graduate