Senior QA Specialist - Tech Transfer / NPI - Biotech - Dublin

Office/Project Location: Dun Laoghaire, Dublin

Employment Type: Contract

Pay: Hourly Rate €60 - €70 per hour

Experience: 8+ years' experience in pharmaceutical/biotech QA, with direct Tech Transfer / NPI experience

Visa: EU passport or Stamp 4 visa required

Our client is a premier global biopharmaceutical manufacturing company operating state-of-the-art commercial sterile manufacturing facilities in Ireland.

The Senior QA Specialist (Tech Transfer / NPI) is required to provide Quality Assurance leadership and oversight across cross-functional Technology Transfer and New Product Introduction (NPI) project teams supporting product transfers onto new and existing filling lines.

Based in Dublin / Kildare, they will act as the dedicated QA voice within project teams—ensuring tech transfer planning, change controls, Process Performance Qualification (PPQ) protocols, batch record readiness, and validation deliverables are fully compliant with cGMP and regulatory standards.

Serve as the primary QA Lead / Representative for Tech Transfer and NPI project teams throughout the complete product lifecycle from knowledge transfer to commercial execution

Review and approve tech transfer documentation, including process descriptions, transfer plans, PPQ protocols/reports, risk assessments, and technical validation summaries

Lead and manage complex NPI change controls, ensuring sending and receiving site process differences are risk-assessed, controlled, and aligned with regulatory filings

Provide critical QA oversight for process characterization, engineering demonstration runs, and PPQ readiness decision gates

Assess deviations, CAPAs, change controls, and technical risks arising during transfer execution prior to commercial release

Review and approve operational readiness documentation, including electronic batch records (eBR), automation recipes, BOMs, sampling plans, SOPs, and contamination control strategies

Maintain QA oversight over integrated line qualification, media fills, environmental monitoring qualifications, and equipment validation for filling, lyophilisation, and aseptic processing

Partner closely with Process Development, Engineering, Manufacturing, Validation, QC, and Regulatory teams to drive audit-ready tech transfer execution

Requirements

Bachelor’s or Master’s degree in Science, Engineering, Biotechnology, or a related discipline

8+ years' QA experience within a cGMP pharmaceutical or biopharmaceutical manufacturing environment

Direct experience serving as a Senior QA Representative / Lead on Technology Transfer, NPI, process validation, or PPQ projects

Strong background in sterile drug product manufacturing, aseptic processing, vial or syringe filling (biologics drug substance experience with strong transferable tech transfer skills will also be considered)

Expertise in quality risk management (ICH Q9), change control systems, deviation/CAPA investigations, and validation lifecycle frameworks

Strong capability to challenge cross-functional project teams, assess quality impact, and drive risk-based commercial decision-making

Package

Hourly Rate €60 - €70 per hour depending on experience

12 month initial contract

Contact

Karen McHugh is the consultant managing this position.

If you are a Senior QA Specialist interested in roles based in Dublin, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720 for a confidential chat.

JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Senior QA Specialists in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individual.

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