Description

Lead Computer System Validation (CSV) activities for manufacturing applications within a GxP regulated environment.

Responsibilities

• Execute end-to-end validation for SAP, Product Serialization, and MES systems.
• Perform compliance analysis and reviews of GxP systems to ensure regulatory alignment.
• Author Validation Plans, Validation Summary Reports, and Requirements Traceability Matrices (RTM).
• Manage change requirements by delivering implementation plans, impact assessments, and test results.
• Review pre-executed and post-executed test protocols for accuracy, evidence, and completeness.

Required Skills

• 4+ years of experience in validating SAP systems within a manufacturing context.
• Hands-on experience with Computer System Validation (CSV) using Agile methodology.
• Proficiency with Agile and Waterfall software development lifecycles.
• Practical knowledge of ALM, DMS, and JIRA.
• Experience with SAP Systems, Product Serialization systems, and MES systems.
• Ability to perform document and process compliance analysis.
• Experience managing defect processes and traceability.

Preferred Skills

• Any Graduate degree.

Key Skills

Education

Any Gradute