1 of 1 Permanent GAMP Jobs in the North of England

the validation and lifecycle management of both custom-built and commercial off-the-shelf (COTS) systems used throughout our pharmaceutical operations. This role is essential to ensuring compliance with GAMP 5 guidelines and global regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11), while also supporting a company-wide risk stratification initiative for all GxP-relevant systems. As … Specialist your responsibilities will include, although not limited to: Leading and executing validation activities for new and existing computerised systems, including both bespoke and COTS solutions, in accordance with GAMP 5 principles. Performing risk assessments to define the appropriate validation strategy and documentation scope, aligned with the organisation’s overall GxP risk stratification framework. Preparing and maintaining validation documentation, including … demonstrate: Bachelor's degree in a scientific, engineering, or IT-related field. Minimum of 3 years’ experience in CSV within the pharmaceutical or life sciences industry. Strong understanding of GAMP 5, data integrity requirements, and applicable regulatory frameworks. Demonstrated experience with both bespoke and COTS systems across a range of GxP areas (e.g., manufacturing, quality control, clinical operations). Excellent More ❯