Quality Assurance Specialist (hybrid)
RK4870
Contract 12 months
Dublin


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



This role will ensure quality and compliance across integrated line qualification, media fill execution, and product introduction activities, working closely with Engineering, Operations, and Process Development teams.



Duties:

• Provide QA leadership during design of new rooms, development of materials/people/waste flows and contamination controls (gowning, cleaning, disinfection)ensuring operational robustness. QA review/approve associated risk assessment and SOP.
• Review and approve validation documentation including integrated line PQs, media fills, and environmental monitoring qualifications.
• Support QA review of MBR and recipe creation for filling, lyophilisation, and associated aseptic operations.
• Ensure readiness of operational documentation including SOPs, batch records, and contamination control strategies.
• Contribute to the review of contamination control, isolator qualification (including smoke studies and VHP qualification), and environmental monitoring performance qualification (EMPQ).
• Maintain oversight of validation and readiness documentation to ensure it is audit-ready, scientifically sound, and compliant with company standards and cGMP.
• Serve as the QA Lead for technology transfer and NPI activities, providing quality oversight throughout process validation and product lifecycle introduction.
• Review and approve technology transfer documentation including process descriptions, PPQ protocols, validation reports, and risk assessments.
• Partner cross-functionally with Technical, Engineering, and Operations teams to ensure all NPI activities are compliant with regulatory and site quality requirements.
• Ensure alignment of transfer activities with companies global validation and quality system standards.
• Lead and support deviation, CAPA, and change control management related to operational readiness, validation, and tech transfer activities.
• Conduct quality risk assessments for new processes, interventions, and aseptic operations.
• Ensure data integrity and right-first-time execution across all readiness and validation deliverables.
• Support inspection readiness and regulatory audits, representing QA for validation and NPI areas.

• Bachelor’s or Master’s degree in Science, Engineering, Biotechnology, or related discipline.
• Minimum 8 years’ experience in pharmaceutical or biotechnology manufacturing
• Proven expertise in facility startup and Quality Oversight of Operational Readiness and and technology transfer activities.
• In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections including EU/FDA GMP, Annex 1, and process validation lifecycle requirements.
• Experience working in aseptic operations, relating to vial and syringe filling.
• Experience managing change control, deviations, and CAPAs through electronic QMS systems (e.g., TrackWise, Veeva Vault, PAS-X, SAP).