Computer Systems Validation Specialist
Core
Ensure health authority regulated computer systems are implemented in accordance with regulatory codes (PIC/S, FDA CFR) and industry standard guidelines (GAMP) for Government agencies and SMEs.
Role type
Computer Systems Validation Specialist
Builds
Validated IT systems for Government agencies and Small to Medium Enterprises
Domain
Pharmaceutical/Healthcare IT and Regulatory Compliance
Required skills
Computer Systems Validation (CSV), GAMP 5, System Development Life Cycle (SDLC), Good Manufacturing Practice (GMP), FDA 21 CFR Part 11, PIC/S Annex 11, Validation Master Plan creation, Risk Assessment, Test Protocol execution, Quality Change Control, Technical writing, GxP regulations
Preferred skills
Quality Management Systems (QMS), Vendor management, Troubleshooting GMP IT implementations
Technologies
GAMP 5, FDA CFR, PIC/S, 21 CFR Part 11, GxP
Responsibilities
Create and support validation artefacts (Validation Master Plan, IQ/OQ/PQ protocols, Traceability Matrix); Facilitate functional risk assessments; Plan and execute validation activities; Maintain validated state of regulated systems; Train stakeholders; Liaise with vendors; Prepare test documentation for GMP systems.
Seniority
Senior, hands-on IC