IT Quality Assurance (IT QA) Specialist – Pharmaceutical
Work Arrangement:
First 2 weeks onsite for onboarding, system familiarization, and project kickoff; remote thereafter.
We are seeking an experienced
IT Quality Assurance (IT QA) Specialist
to support computerized systems and digital applications within a regulated pharmaceutical or biotechnology environment. The ideal candidate will have strong knowledge of
GxP, Computer System Validation (CSV/CSA), data integrity, and FDA 21 CFR Part 11 requirements
.
Responsibilities
Provide IT Quality oversight for GxP computerized systems throughout the system lifecycle.
Review and approve validation documentation including
URS, risk assessments, validation plans, IQ/OQ/PQ, test scripts, traceability matrices, and validation summary reports
.
Review and approve
change controls, deviations, CAPAs, incidents, and system-related investigations
.
Ensure computerized systems comply with
21 CFR Part 11, GAMP 5, ALCOA+ data integrity principles, and applicable GMP requirements
.
Support periodic reviews, access/security reviews, audit-trail reviews, system assessments, and retirement activities.
Provide QA oversight for system upgrades, patches, configuration changes, interfaces, and data migration.
Collaborate with IT, QA, CSV, system owners, business users, and vendors.
Support internal audits and regulatory inspections involving computerized systems.
Qualifications
5+ years of IT QA, CSV, or Computer Systems Quality experience in pharmaceutical, biotech, or life sciences.
Strong knowledge of
GxP computerized systems, SDLC/CSV lifecycle documentation, 21 CFR Part 11, GAMP 5, CAPA, deviations, and change control
.
Experience with
LIMS, MES, SAP/ERP, QMS, EDMS, laboratory systems, or manufacturing applications
preferred.