Overview
QA Validation Specialist CSV (Fully Remote) Jobs in Ireland at DPS Group Global
Title: QA Validation Specialist CSV (Fully Remote)
Company: DPS Group Global
Location: Ireland
A leading global pharmaceutical organisation is currently seeking an experienced CSV QA Specialist to support a large portfolio of global validation projects.
This is a fully remote role, with a preference for candidates based in Ireland.
The CSV QA Specialist will provide quality oversight of computer system validation (CSV) activities across global projects, ensuring compliance with GxP regulations and internal standards. This role focuses on QA validation, documentation review, and risk-based oversight of system lifecycle activities.
Key Responsibilities
- Provide QA oversight of CSV activities across global IT and GxP systems
- Review and approve key validation deliverables including:
- Validation Plans & Reports
- Requirements & Traceability Matrices
- Test Plans, UAT, and test results
- Data migration documentation
- Ensure compliance with GxP, data integrity, and 21 CFR Part 11 / Annex 11 requirements
- Support change control and validation lifecycle activities
- Identify and manage GxP risks, deviations, and CAPAs
- Support audit and inspection readiness
- Provide guidance to cross-functional teams on CSV, data integrity, and QA processes
Requirements
- Degree in a scientific or engineering discipline
- 5+ years’ experience in CSV / Computer System Validation (QA or hands-on)
- Strong experience in GxP-regulated pharma environments (essential)
- Knowledge of 21 CFR Part 11, Annex 11, and data integrity principles
- Experience reviewing validation lifecycle documentation (SLC)
- Experience working on global or complex IT / validation projects
- Strong stakeholder engagement and communication skills
Nice to Have
- Experience with SAP, LIMS, or ELN systems
- Experience in API, biologics, or OSD manufacturing environments
- Previous QA validation oversight experience
