Description

You will lead Computer System Validation (CSV) activities for manufacturing-related applications and SAP systems.

Responsibilities

• Perform compliance analysis and reviews for GxP systems to ensure regulatory alignment.
• Review requirement specifications, functional specifications, user stories, and acceptance criteria to ensure test script completeness and traceability.
• Execute risk assessments for all requirements and design test cases based on identified risk levels.
• Review pre-executed and post-executed test protocols for accuracy, evidence, and data requirements.
• Author Validation Plans, Validation Summary Reports, and Requirements Traceability Matrices (RTM).
• Manage change requirements by handling implementation plans, impact assessments, and defect management.

Required Skills

• 10+ years of experience validating SAP systems within a manufacturing environment.
• Extensive experience in Computer System Validation (CSV) for SAP, Product Serialization, and MES systems.
• Proven experience with both Agile and Waterfall software development methodologies.
• Deep understanding of end-to-end validation for GxP applications.
• Proficiency using ALM, DMS, and JIRA.
• Hands-on experience with DSCSA and Product Serialization systems.
• Ability to manage the full validation lifecycle from planning to summary reporting.

Preferred Skills

• Experience implementing US-DClientA.

Key Skills

Education

Any Gradute