Quality Validation Specialist
Job Summary
To ensure the quality of IT Validation & Compliance infrastructure in a CDMO setting, the full-time Principal Specialist - Quality Validation will oversee enterprise software validation, review and approve validation lifecycle deliverables, and manage quality oversight of change controls, CAPAs, and deviations while working remotely.
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 global initiatives related to data integrity
Required qualifications
- BS with 8+ years or MS with 6+ years of experience in a QA or GMP environment
- Expert knowledge of 21CFR Part 11 and/or EU Annex 11
- Experience in Data Integrity, computer system validation, and IT quality in an FDA regulated manufacturing environment
- Ability to read, analyze, and interpret complex documentation and regulations
- Willingness to travel approximately 10% domestically and internationally
Complete Job Description
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