Description

You will manage validation activities and regulatory compliance for enterprise applications and quality systems.

Responsibilities

• Conduct risk analyses and reviews, approving validation test scripts and incident reports.
• Execute change control activities for system enhancements, defect fixes, and data migration.
• Implement GxP requirements (GMP, GDP, GLP, GCP) across various regulated systems.
• Manage system decommissioning, overseeing data migration and archival from legacy systems.
• Coordinate with cross-functional teams to complete validation deliverables and periodic reviews.

Required Skills

• 3+ years of experience in software engineering or related validation roles.
• Proficiency with HP ALM for test management.
• Hands-on experience with Salesforce.com and SAP.
• Competency in ServiceNow and DocuSign.
• Familiarity with Workday, Concur, and Coupa.
• Strong competency in SharePoint and Office 365.
• Knowledge of regulatory assessment, validation plans, and test scripts.
• Experience drafting User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
• Ability to manage Data Migration Plans and Data Migration Summary Reports.
• Understanding of Deviation Logs, Testing Summary Reports, and Validation Summary Reports.

Key Skills

Education

Any Graduate