I've supported GxP-regulated systems for Cignus Solutions clients including CSL Vifor (Relypsa) and Ironwood Pharmaceuticals, managing validation, releases, change controls, periodic reviews, and system retirements.
I develop and execute risk-based CSV/CSA deliverables across the system lifecycle, from requirements and risk assessments through IQ/OQ/PQ, traceability, deviations, CAPA, and validation summary reports. My work aligns with GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, data integrity, and ALCOA+ expectations.
I also provide Tier 2 and Tier 3 GxP system administration for platforms including ComplianceWire, OpenText Content Server, IQVIA CIRRUS, TriNetX Evidex, DocuSign, and ServiceNow.
Previously, I supported CSV validation projects at Validation Associates for QPHARMA Pharmaceuticals, including GxP system administration, SDLC documentation, testing, and EU pharmaceutical audit support.
