Quality Assurance Specialist - Tech Transfer / NPI
Hybrid
RK5676
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.



The primary focus of this role is to provide QA leadership and oversight within cross-functional Technology Transfer and New Product Introduction project teams, supporting the transfer of products onto new and existing filling lines. The successful candidate will act as the QA voice in the project team, ensuring transfer activities are appropriately planned, risk assessed, documented, executed and closed in line with company standards, cGMP and regulatory expectations.



Key Responsibilities:

• Serve as the QA lead / QA representative for technology transfer and NPI project teams.
• Provide quality oversight throughout the product transfer lifecycle, from initial knowledge transfer and transfer planning through to PPQ / process validation, submission support and commercial readiness.
• Review and approve technology transfer documentation, including process descriptions, transfer plans, process validation / PPQ protocols and reports, risk assessments, validation reports and supporting technical documentation.
• Support the development and approval of introduction change controls, ensuring transfer scope, product/process impact, regulatory impact, validation requirements and implementation tasks are appropriately defined.
• Ensure sending and receiving process differences are understood, risk assessed and appropriately controlled.
• Provide QA input to process characterisation, engineering / demonstration runs and PPQ readiness decisions.
• Ensure batch record, recipe, BOM, sampling and testing readiness are appropriately controlled for transferred products.
• Lead and support deviation, CAPA and change control management related to technology transfer, PPQ, validation and operational readiness activities.
• Provide QA input to quality risk assessments, including product transfer risk assessments, process risk assessments, contamination control assessments and validation risk assessments.
• Support investigation and impact assessment of issues arising during transfer execution, engineering runs, PPQ batches or readiness activities.
• Act as a proactive QA partner to project teams, ensuring issues are identified early and resolved through compliant, risk-based decision-making.
• Review and approve documentation related to integrated line qualification, media fills, environmental monitoring qualifications, equipment qualification and associated readiness activities.
• Support development of, electronic batch records, automation recipes and associated manufacturing documentation for filling, lyophilisation and aseptic operations.
• Ensure operational documentation, including SOPs, batch records, contamination control strategies and training requirements, is ready to support transfer execution.
• Maintain QA oversight of validation and readiness documentation to ensure it is audit-ready, scientifically sound and compliant with company standards and cGMP.

• 8 years’ experience in pharmaceutical or biotechnology manufacturing
• Bachelor’s or Master’s degree in Science, Engineering, Biotechnology, or related discipline
• Strong QA experience in a GMP pharmaceutical or biopharmaceutical manufacturing environment.
• Direct experience supporting technology transfer, NPI, process validation or PPQ activities.
• Experience acting as QA lead or senior QA representative within cross-functional project teams.
• Sterile drug product, aseptic manufacturing, vial or syringe filling experience is strongly preferred.