Description

You will lead end-to-end validation activities for GxP-regulated applications including SAP, MES, and Product Serialization.

Responsibilities

• Execute and manage validation lifecycles, including GxP risk assessments, change management, and compliance analysis.
• Author and review validation deliverables such as Validation Plans, Protocols, and Summary Reports.
• Maintain traceability from requirement specifications through testing and final compliance.
• Lead validation efforts using both Agile and Waterfall methodologies.
• Serve as the primary point of contact for compliance and assurance services across functional and geographic scopes.

Required Skills

• 10+ years of experience validating GxP-regulated applications.
• Deep expertise in Computer System Validation (CSV) within the life sciences domain.
• Hands-on experience with GxP compliance frameworks such as GAMP.
• Proficiency with IQ/OQ/PQ processes.
• Experience with JIRA, ALM, and Document Management Systems.
• Direct experience using Veeva and Argus.
• Ability to perform roles including CSA (Computer System Assurance), Validation SME, and Test Manager.
• Strong documentation, analytical, and stakeholder management capabilities.

Preferred Skills

• Experience with US-DSCSA implementations.

Key Skills

Education

Any Gradute