Quality Validation Principal Specialist

Job Summary

A company is looking for a Principal Specialist - Quality Validation.

Key Responsibilities

• Provide quality assurance review and approval for validation lifecycle deliverables of enterprise software projects
• Oversee quality assurance review and approval of enterprise software Change Controls, CAPAs, and Deviations
• Support Data Integrity global initiatives and remediation

Required Qualifications

• BS with 8+ years or MS with 6+ years of experience in a QA or GMP environment or equivalent
• Expertise in Computer System Validation and IT Quality in an FDA regulated manufacturing environment
• Knowledge of 21CFR, Part 11, and/or EU Annex 11
• Familiarity with ISPE GAMP 5 Guidance for compliant GxP computerized systems
• Ability to analyze and interpret validation lifecycle documentation