Company DescriptionMilestone, a division of the global PM Group, provides advanced automation and digital systems consultancy services, specializing in Life Sciences and FMCG sectors. With a team of over 160 experts, we bring a comprehensive perspective to project implementation through our experience as end users, engineering consultants, and system integrators. Our service offerings include digital factory delivery, system integration, compliance, and manufacturing intelligence among others, ensuring tailored solutions for business needs. As part of the employee-owned PM Group, which operates in Europe, the UK, USA, and Asia, Milestone combines decades of expertise with a commitment to optimizing client outcomes.Compliance AnalystThe Compliance specialist provides IT compliance/validation support to the AIT team in Carlow and the general site to ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle (SDLC), Cyber Security and Data Integrity for manufacture and supply of quality pharmaceutical products.Primary ResponsibilitiesEnsure compliance with Global SDLC/CSV and IT Security policies and proceduresEnsure supply of all compliance components required to deliver high quality product through tactical planning and execution of project and compliance deliverables; including change-control, periodic reviews, performance monitoring, system administration, access administration, disaster recovery, deviations, incident problem management/investigations, CAPAs, audits, policy deployment, cyber security, data integrity, EHS, training etc.Participate and Comply with the MMD Quality Management System (QMS) requirements, including Chapter 14 (Computer Systems) and EU Annex 11, 21 CFR Part 11, MHRA (UK) GMP Data Integrity guidelines, Sarbanes-Oxley (SOX) regulations.Qualification and ExperienceAbility to participate in highly effective teams.Ability to work with all levels of business customers in a highly dynamic environment.Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site.Strong verbal and written communication skills, project management skills.Minimum Education/ExperienceDegree qualification (Science, Engineering, Technical).3-5 years GxP experience in Computer System Validation (life science, pharma, medical devices).