Job Title: Quality Assurance Senior Specialist – CSV / CQV (Contract)Location: Dundalk, Co. LouthWork Mode: Fully Onsite (No Hybrid / Remote)Role OverviewAn excellent contract opportunity has arisen for a Quality Assurance Senior Specialist (CSV/CQV) to support a manufacturing facility during a critical start-up and transition phase. The role reports to the QA CSQ/CQV Lead and is responsible for providing QA oversight of all validation and qualification activities, ensuring full compliance with cGMP, regulatory requirements, and internal SOPs.This role plays a key part in supporting Commissioning, Qualification, and Validation (CQV) activities and ensuring a smooth transition from project execution to routine commercial operations.Key Responsibilities:Provide QA oversight for qualification and validation of:Facilities, utilities, and equipmentComputerized systems (CSV)Cleaning and manufacturing processesStorage areas, CTUs, and shipping processesReview and approve validation documentation including:Validation plans, URS, risk assessments, protocols, and reportsEnsure QA oversight of deviations, investigations, and change controls arising during validation activitiesReview and approve SOPs related to qualification and validationSupport regulatory inspections and client auditsMaintain validation status of the facility in line with cGMP requirementsCoordinate QA validation activities to ensure schedule adherence and timely deliveryProvide subject matter expertise across CSV and CQV activitiesSupport and guide validation teams as requiredEducation & Experience Requirements:Bachelor's degree (BSc or BEng) in a Scientific or Engineering disciplineProven experience in QA, Quality Engineering, or Validation roles within:Pharmaceutical, biologics, or medical device manufacturingFDA / EU regulated environmentsStrong understanding of cGMP manufacturing facility validation requirementsHands-on experience with computer system validation (CSV)Technical Knowledge & ExpertiseStrong knowledge of GxP regulations (EU GMP, FDA, ISO)Familiarity with industry standards including:GAMP 5, ISPE, ISO, ASME, BPEExperience with:Root cause analysis tools (FMEA, Ishikawa, etc.)Risk-based validation approachesKey Skills:Independent and self-motivatedStrong planning, organisational, and time management skillsAbility to work in fast-paced, project-driven environmentsExcellent critical thinking and problem-solving skillsAbility to work cross-functionally with internal and external stakeholders