Description

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

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.
• Guide change leads to ensure compliance with established procedures and SDLC deliverables.
• Implement GxP requirements (GMP, GDP, GLP, GCP) into existing systems.
• Coordinate with cross-functional teams to meet project schedules for validation and system decommissioning.

Required Skills

• 3+ years of experience in regulatory assessment and validation planning.
• Experience developing User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
• Proficiency in managing Test Scripts, Testing Summary Reports, and Validation Summary Reports.
• Knowledge of Deviation Logs, Production Support Plans, and Data Migration Plans.
• 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 data migration and archival from legacy systems.

Key Skills

Education

Any Graduate