alignment with business objectives and IT roadmaps. Establish testing policies, standards, and best practices in collaboration with process experts to ensure consistency, quality, and compliance with regulatory requirements (e.g., GXP, GDPR, and other pharmaceutical industry standards). Define key performance indicators (KPIs) and metrics to measure testing effectiveness, leveraging input from process teams to assess system reliability and defect resolution More ❯
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 a CSV 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 User Requirements Specifications (URS), Functional Specifications (FS), validation plans, protocols, reports, and traceability matrices. Working collaboratively with IT, QA, system owners, and vendors to ensure … compliant manner. Providing support during audits and regulatory inspections, addressing data integrity and CSV-related queries. Ensuring all system lifecycle documentation is maintained in accordance with internal SOPs and GxP standards. Assisting in developing implementing and testing disaster recovery plans for key computerised systems in collaboration with business departments. Contributing to the continuous improvement of CSV procedures, templates, and best More ❯
