Position SummaryThe QA Systems & Validation Specialist is responsible for ensuring that all GMP-related changes, systems, and validation activities comply with regulatory requirements and site Quality standards.This role provides subject matter expertise across change control, validation, and quality systems, supporting manufacturing, laboratory, engineering, and IT operations within a regulated pharmaceutical environment.Key ResponsibilitiesQuality Systems & Change ControlAssess GMP impact of changes in accordance with site Change Control procedures for:Facilities and utilitiesLaboratory and manufacturing equipmentControl and automation systemsEnsure changes are appropriately evaluated, documented, and approved for GMP compliance.Validation & ComplianceProvide validation expertise to ensure compliance with current industry regulations, guidelines, and best practices.Review and approve master and executed qualification and validation documentation, including protocols, reports, and supporting data, ensuring conformance with:Regulatory requirementsSOPsSpecifications and acceptance criteriaValidation activities include but are not limited to:Qualification of premises, equipment, and utilitiesComputer System Validation (CSV)Laboratory equipment validationSupport of New Product Introductions (NPIs)Capital Projects & Design ReviewReview and approve GMP-relevant design aspects of major capital projects, including:New facility constructionFacility upgradesNew manufacturing equipment and support systemsCross-Functional CollaborationWork closely with Manufacturing, Quality Control, Utilities, Engineering, Automation, and IT teams.Participate in cross-functional projects as directed by the Quality Systems & Validation Manager.Regulatory & Quality StandardsEnsure quality systems are implemented and executed in compliance with:ICH Q7EudraLex21 CFR requirementsSite Quality standardsSupport data integrity initiatives, including compliance with GMP data integrity requirements and regulatory expectations.Skills & CompetenciesStrong interpersonal, communication, and presentation skillsExcellent organisational, time management, and multi-tasking abilitiesStrong attention to detail and risk-based decision-making skillsAbility to work independently and collaboratively in a regulated environmentMinimum RequirementsBSc or BE ngin Chemistry, Engineering, or a science-related disciplineMinimum 3 years' pharmaceutical industry experience, ideally in a QA roleExperience with Change Control, documentation management, and GMP complianceKnowledge or appreciation of site operations including QC, Manufacturing/Operations, Engineering, and ITFamiliarity with Data Integrity regulatory requirements