CSV Specialist - Bloomington, IN
Only for registered members Bloomington, IN , United States
4 weeks ago
Job summary
The CSV Specialist will plan execute and document validation activities for GxP-regulated computerized systems.This role supports system lifecycle activities audits and compliance initiatives while ensuring adherence to FDA CSA guidance 21 CFR Part 11 EU Annex 11 GAMP 5 and ALCOA+ principles.
- Author and execute CSV deliverables including URS FS/DS Validation Plans VP Risk Assessments RA IQ / OQ / PQ Traceability Matrices Validation Summary Reports
- Serve as a CSV Subject Matter Expert SME during audits and inspections
- Support change control periodic reviews and system lifecycle management
- Partner with IT QA Operations and Laboratory teams
- Earn data integrity compliance per ALCOA+ principles
Benefits
- GAMP training ASQ certifications: CQA CSQE CQE PMP or Agile certification
Job description
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