Test Lead

Validation Responsibilities and Job Description Summary

Ownership of Validation Artifacts

• Leads the help for creation, review, and approval of validation documents such as:
• Validation Plans
• Test Plans
• Security Plans
• Validation Summary Reports
• Requirements Traceability Matrices etc.
• Review CR

Creation/Performance of CAPA

Cross-Functional Collaboration

• Works closely with system owners, business SMEs, test leads, and quality assurance teams to ensure validation deliverables meet compliance and operational standards.
   

Regulatory Compliance

• Ensures validation activities align with regulatory expectations (e.g., GCP, FDA, CSA), and supports audit readiness.
   

Project Leadership

• Coordinates validation timelines, manages document routing and approvals, and ensures testing cannot proceed without validated documentation.
   

Tool & System Familiarity

• Uses platforms like Jira, ALM, and internal document management systems (e.g., Qdocs) for validation tracking and documentation.
   

Review & Routing.

• Often the final reviewer in validation workflows, ensuring completeness and compliance before sign-off.