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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
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COMPLETE JOB DESCRIPTION
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