Description

You will lead validation efforts for GxP applications within FDA and global regulated environments.

Responsibilities

• Manage the full validation lifecycle, including IQ, OQ, and PQ pre- and post-execution documentation.
• Review and approve technical design, solution architecture plans, user stories, URS, and FRS.
• Lead the creation and approval of discrepancy logs, Requirement Traceability Matrices (RTM), and Validation Summary Reports.
• Execute risk assessments and provide consultation on Risk and Compliance module implementations.
• Oversee periodic reviews of GxP applications, manage findings, and close CAPAs.

Required Skills

• 10+ years of experience validating GxP applications.
• Deep understanding of GCP, GLP, and risk-based validation strategies.
• Experience working in FDA or other global regulated environments.
• Proficiency in SQL, .Net, HTML, and CSS.
• Ability to document regulatory requirements and review technical specifications.
• Strong communication skills for handling multiple clients and projects.
• Experience creating project plans and tracking schedules to meet quality standards.

Preferred Skills

• Experience with clinical systems such as CTMS, CDMDS, EDC, Veeva Vault, QMS, and Safety Systems.
• Experience with infrastructure qualification.

Key Skills

Education

Any gradudate