The Computer System Validation (CSV) Specialist is responsible for the validation of GxP computerised systems, including the preparation of validation documentation and execution of testing activities. This role ensures systems are compliant with regulatory requirements and support operational excellence within a GMP-regulated environment.
Key Responsibilities
Manage and execute qualification and validation activities for GxP computerised systems.
Support project planning and provide real-time status updates on validation deliverables.
Prepare, review, and approve validation documentation, including validation plans, protocols, reports, and risk assessments.
Support the investigation and closure of deviations arising during validation activities, including troubleshooting where required.
Contribute to and support periodic review processes for validated systems.
Ensure data integrity requirements are maintained throughout the system validation lifecycle.
Ensure compliance with regulatory requirements and industry standards, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
Maintain compliance with relevant ISO standards (ISO 14001, ISO 45001), health & safety regulations, environmental legislation, and site procedures.
Required Qualifications & Experience
Bachelor’s degree in a scientific or engineering discipline.
Extensive experience working within a GMP-regulated environment.
Strong knowledge of validation requirements for GxP computerised systems, including QC laboratory systems.
Ability to work independently, demonstrate initiative, and communicate effectively within a team environment.
Preferred Qualifications
Experience in a manufacturing site-based cGMP environment.
Hands‑on experience in computer system validation, including QC laboratory systems.
Strong analytical and problem‑solving skills.
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