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 activities
* Review/approval of validation protocols and reports (process, cleaning, equipment)
* Close collaboration with development and operations teams
* Supporting compliance activities - deviations, CAPAs, change control, risk assessments
* Ensuring documentation and execution meet cGMP and global quality standards
* Participating in audit readiness and supporting internal/external inspections, ensuring validation and tech-transfer activities align with regulatory expectations
* Reviewing and ensuring data integrity compliance across validation, tech transfer, and manufacturing documentation
* Providing QA input into continuous improvement initiatives, including process robustness, documentation enhancements, and quality system optimisation
QA Executive - Requirements:
* Bachelor's or Master's degree in Life Sciences, Engineering, Pharmacy, Biotechnology, or a related discipline
* 3-5+ years of QA experience in a pharmaceutical/biopharmaceutical GMP environment, ideally supporting tech transfer and/or validation activities
* Strong understanding of biologics, aseptic processing, plasma-derived therapies, or other highly regulated manufacturing is an advantage
* Solid knowledge of cGMP, ICH, EMA/FDA regulatory expectations, and global quality systems
* Proven experience reviewing and approving validation documentation (process, cleaning, equipment)
* Familiarity with technology transfer, scale-up, and introduction of new products/processes into manufacturing
* Competence in quality systems including deviation management, CAPA, change control, and risk assessment methodologies (FMEA, HACCP, etc.)
* Understanding of data integrity principles and batch documentation requirements
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us