Senior Digital QA Engineer — Hybrid, AI-Enabled GxP Systems
Axiom Path, Inc.
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Job summary
Zohorecruit in Bridgewater, NJ seeks a Senior Digital Systems Quality Assurance Engineer to oversee GxP computerized systems across validation, operation, and retirement. You will ensure systems are validated, compliant, and controlled, supporting patient safety, data integrity, and regulatory readiness in a fast-moving environment.
This role requires deep knowledge of 21 CFR Part 11, EU GMP Annex 11, ISPE GAMP 5, and risk-based validation, with hands-on QA oversight for SaaS, cloud-hosted, and
Qualifications
- Bachelor's degree in life sciences, engineering, computer science or related field.
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Responsibilities
- Provide independent QA oversight for GxP computerized systems across lifecycle.
- Review validation plans, tests, and lifecycle deliverables for regulatory alignment.
- Ensure systems remain validated, compliant, and in controlled state.
- Evaluate risks related to patient safety, product quality, and data integrity.
- Support inspection readiness, supplier qualification, and regulatory audits.
- Collaborate with CSV, IT, business owners, and vendors to implement compliant solutions.
Skills
Education
Tools
Job description
Zohorecruit in Bridgewater, NJ seeks a Senior Digital Systems Quality Assurance Engineer to oversee GxP computerized systems across validation, operation, and retirement. You will ensure systems are validated, compliant, and controlled, supporting patient safety, data integrity, and regulatory readiness in a fast-moving environment.
This role requires deep knowledge of 21 CFR Part 11, EU GMP Annex 11, ISPE GAMP 5, and risk-based validation, with hands-on QA oversight for SaaS, cloud-hosted, and
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