Role PurposeThe Quality Assurance Specialist plays a key role in supporting the delivery of high-quality, compliant validation documentation and quality processes across Gallarus Industry Solutions. Working under the QA Lead, the role is primarily focused on supporting project-based validation work for pharmaceutical and industrial clients – including the development of validation documentation in line with GAMP 5 and CSV/CSA principles, data integrity requirements, and applicable regulatory frameworks. The role also supports the ongoing operation of the GIS Quality Management System, contributing to ISO compliance activities as a secondary responsibility.The ideal candidate is methodical, detail-oriented, and comfortable working across concurrent client projects in a consultancy environment.Key Responsibilities1. Validation Documentation & Project SupportDevelop, review, and maintain validation documentation in accordance with GAMP 5 and CSV/CSA principles, including VMPs, Risk Assessments, URS, FDS, SAT/FAT protocols, RTMs, and associated evidence appendices.Apply data integrity principles and ALCOA+ throughout documentation and execution activities.Support test planning and protocol development for system acceptance testing (UAT/SAT/FAT), working with project engineers to understand requirements and translate them into testable criteria.Execute and support test activities on-site or remotely, documenting results accurately and in real time in line with GxP expectations.Raise, track, and close deviations, defects, and open items arising during test execution, ensuring complete and traceable records.Contribute to requirements traceability matrix (RTM) development and maintenance across project lifecycles.Support IQ/OQ/PQ activities as required across project lifecycles, with an understanding of phase-appropriate documentation requirements.Work within applicable regulatory frameworks for computerised systems validation, ensuring documentation meets compliance requirements.Maintain clear audit trails for all validation document changes and approvals in line with GxP and data integrity requirements.2. Quality Management System & ISO Compliance SupportOperate document control processes including version control, review coordination, sign-off tracking, and archiving in line with GIS IMS and ISO requirements for documented information.Maintain document repositories to ensure accessibility, organisation, and traceability across active and completed projects.Provide documentation packages to support internal and external audit and inspection activities.Support the day-to-day operation of the GIS Integrated Management System (IMS), covering ISO 9001, ISO 14001, ISO 27001, and ISO 45001.Contribute to internal audit preparation and execution, including supporting the bi-annual ISO management review cycle.Assist with quality metrics collection, trend analysis, and reporting for compliance dashboards and management review inputs.Support the maintenance and continuous improvement of improvement logs, NCR tracking, and corrective/preventive action (CAPA) processes.Help identify and implement process improvements to documentation practices, tools, and QMS procedures.Person SpecificationEssentialBachelor’s degree in Life Sciences, Engineering, Computer Science, or a related field, or equivalent industry experience.Minimum 5 years’ experience in a Quality Assurance or validation role within a pharmaceutical, biotech, or regulated industry environment.Working knowledge of GAMP 5 and CSV/CSA principles, including the computerised system validation lifecycle.Familiarity with data integrity principles and ALCOA+ in the context of GxP documentation and test execution.Awareness of applicable regulatory frameworks for computerised systems validation (e.g. 21 CFR Part 11, EU GMP Annex 11) — expected to develop through project exposure.Experience developing or contributing to validation documentation: VMPs, Risk Assessments, URS, FDS, SAT/FAT protocols, RTMs, or equivalent.Strong written and verbal communication skills – able to produce clear, precise, unambiguous technical documentation and communicate effectively with project and client teams.Comfortable working across multiple concurrent projects in a fast-paced consultancy environment.Good organisational skills with the ability to manage priorities and meet deadlines with limited supervision.Strong attention to detail.Strong critical thinking skills, with the ability to question assumptions and identify gaps in documentation or test coverage.DesirableExposure to computerised systems implementations in a pharma or industrial setting (e.g. eBR, MES, CMMS, IIoT); technical understanding of system architecture an advantage.Knowledge of one or more ISO standards (ISO 9001, ISO 14001, ISO 27001, ISO 45001).Experience using Jira or similar project/issue tracking tools for defect management, task tracking, or audit trail purposes.Awareness of industry bodies such as ISPE.Experience working in a systems integration or engineering consultancy environment.
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