Quality Validation Principal Specialist
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
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
