Description

You will manage system validation, risk analysis, and compliance activities within regulated environments.

Responsibilities

• Review and approve validation test scripts, incident reports, and test protocols for enterprise applications and quality systems.
• Execute change control activities for system enhancements, defect fixes, and data migration projects.
• Implement GxP requirements, including GMP, GDP, GLP, and GCP, into existing systems.
• Coordinate with cross-functional teams to deliver validation documentation according to project schedules.
• Manage system decommissioning, focusing on data migration and archival from legacy systems to replacement platforms.

Required Skills

• 3+ years of experience in system validation or regulated environment administration.
• Proficiency with HP ALM and HPQC.
• Experience with ServiceNow and Jira.
• Hands-on experience with SAP and Salesforce.com.
• Knowledge of regulatory assessment, validation plans, and data migration planning.
• Ability to manage User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
• Competency in creating Test Scripts, Testing Summary Reports, and Validation Summary Reports.
• Experience handling Deviation Logs and Production Support Plans.
• Technical familiarity with SharePoint, Office 365, DocuSign, and Workday.

Key Skills

Education

Any Graduate