Description

You will manage validation activities and regulatory compliance for enterprise systems and quality-critical software.

Responsibilities

• Review and approve validation test scripts, incident reports, and validation test protocols.
• Execute risk analyses and implement GxP requirements including GMP, GDP, GLP, and GCP.
• Manage change control activities for system enhancements, defect fixes, and data migration.
• Coordinate with cross-functional teams to deliver validation documentation and meet project schedules.
• Oversee system decommissioning, focusing on data migration and archival from legacy systems.

Required Skills

• 3+ years of experience in software validation or regulatory assessment.
• Expertise in writing User Requirement Specifications and Functional Requirement Specifications.
• Proficiency in creating Validation Plans, Test Scripts, and Validation Summary Reports.
• Experience managing Deviation Logs and Testing Summary Reports.
• Knowledge of Data Migration Plans and Data Migration Summary Reports.
• Hands-on experience with HP ALM, JIRA, and ServiceNow.
• Technical familiarity with SAP, Salesforce.com, and Workday.
• Competency in using DocuSign, SharePoint, Office 365, and Concur.
• Experience with Production Support Plans and regulatory compliance workflows.

Key Skills

Education

Any Graduate