Mantell Associates is partnered with a leading global biopharmaceutical company, who is searching for a Technical QA Executive to support ongoing tech transfer and validation activities across their development and operations groups.This organisation is a major innovator in rare diseases, oncology and plasma-derived therapies, with a large, modern manufacturing presence in Ireland. They operate in a highly regulated environment, run major tech-transfer programmes, and are known for strong investment in science-driven, patient-focused production.QA Executive - Responsibilities:QA oversight of tech transfer activitiesReview/approval of validation protocols and reports (process, cleaning, equipment)Close collaboration with development and operations teamsSupporting compliance activities - deviations, CAPAs, change control, risk assessmentsEnsuring documentation and execution meet cGMP and global quality standardsParticipating in audit readiness and supporting internal/external inspections, ensuring validation and tech-transfer activities align with regulatory expectationsReviewing and ensuring data integrity compliance across validation, tech transfer, and manufacturing documentationProviding QA input into continuous improvement initiatives, including process robustness, documentation enhancements, and quality system optimisationQA Executive - Requirements:Bachelor's or Master's degree in Life Sciences, Engineering, Pharmacy, Biotechnology, or a related discipline3-5+ years of QA experience in a pharmaceutical/biopharmaceutical GMP environment, ideally supporting tech transfer and/or validation activitiesStrong understanding of biologics, aseptic processing, plasma-derived therapies, or other highly regulated manufacturing is an advantageSolid knowledge of cGMP, ICH, EMA/FDA regulatory expectations, and global quality systemsProven experience reviewing and approving validation documentation (process, cleaning, equipment)Familiarity with technology transfer, scale-up, and introduction of new products/processes into manufacturingCompetence in quality systems including deviation management, CAPA, change control, and risk assessment methodologies (FMEA, HACCP, etc.)Understanding of data integrity principles and batch documentation requirementsMantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us