Quality Assurance - Tech Transfer & NPI

Ascend Project Management; South Dublin; On-site; EUR 85,000 - 120,000; Full time

Job summary

Ascend Project Management is partnering with a leading life sciences company in South Dublin to recruit an experienced Quality Assurance Specialist. You will provide QA leadership for technology transfer and New Product Introduction within a sterile pharmaceutical manufacturing environment.

You will support transfers onto new and existing filling lines, ensuring plans, risk assessments, documentation and execution meet cGMP and regulatory requirements.

Qualifications

• 8+ years in Quality Assurance within GMP pharmaceutical manufacturing.
• Experience supporting technology transfer and NPI; process validation and PPQ.
• Experience as QA lead or senior QA representative in cross‑functional teams.
• Strong knowledge of GMP, change control, deviation/CAPA and validation lifecycle.
• Ability to assess quality impact with risk‑based decisions and challenge teams.
• Strong communication and stakeholder management across technical/operational functions.

Responsibilities

• Act as QA lead for technology transfer and NPI projects, overseeing knowledge transfer, planning, and PPQ readiness.
• Review and approve transfer plans, process descriptions, risk assessments, validation protocols/reports, and change controls.
• Provide QA oversight of process validation, PPQ readiness, line qualification, media fills, environmental monitoring and equipment qualification.
• Ensure batch records, EB/recipes/SOPs/training/docs are prepared and controlled for product introduction.
• Lead deviations, CAPAs, change controls and quality risk assessments related to transfers, validation and PPQ.
• Collaborate with Process Development, Engineering, Manufacturing, Validation, QC and Regulatory teams to address quality issues and ensure regulatory readiness.

Skills

QA leadership

GMP knowledge

Technology Transfer

New Product Introduction

Process Validation

PPQ

Change Control

Quality Risk Management

Cross-functional collaboration

Regulatory awareness

Job description

We are working with a leading life sciences company based in South Dublin to recruit an experienced Quality Assurance Specialist to provide QA leadership and oversight for Technology Transfer and New Product Introduction activities within a sterile pharmaceutical manufacturing environment.

The role will support product transfers onto new and existing filling lines, ensuring activities are appropriately planned, risk assessed, documented and executed in compliance with cGMP and regulatory requirements. The position will work closely with cross‑functional teams across Manufacturing, Engineering, Validation, QC, Regulatory and Process Development to support successful product introduction and commercial readiness.

Key Responsibilities:

• Act as the QA lead or representative for technology transfer and NPI projects, providing quality oversight from initial knowledge transfer and planning through process validation, PPQ and commercial readiness.
• Review and approve transfer plans, process descriptions, risk assessments, validation protocols and reports, technical documentation and change controls, ensuring scope, regulatory impact, validation requirements and implementation activities are appropriately defined.
• Provide QA oversight of process validation, PPQ readiness, engineering and demonstration runs, line qualification, media fills, environmental monitoring, equipment qualification and other operational readiness activities.
• Ensure batch records, electronic batch records, recipes, BOMs, sampling and testing requirements, SOPs, training and contamination control documentation are appropriately prepared and controlled for product introduction.
• Lead and support deviations, CAPAs, change controls and quality risk assessments associated with technology transfer, validation and PPQ activities. Assess quality impacts and ensure risks are appropriately documented, mitigated and controlled.
• Partner with Process Development, Engineering, Manufacturing, Validation, QC and Regulatory teams to identify and resolve quality issues, provide risk‑based QA decisions, challenge project teams where required, and support regulatory and commercial readiness.

Key Requirements:

• A minimum of 8 years' experience in Quality Assurance within a GMP pharmaceutical or biopharmaceutical manufacturing environment.
• Strong experience supporting technology transfer, New Product Introduction, process validation and/or PPQ activities.
• Experience acting as a QA lead or senior QA representative within cross‑functional project teams.
• Strong knowledge of GMP, change control, deviation/CAPA, quality risk management and the validation lifecycle.
• Experience reviewing and approving batch records, validation protocols and reports, PPQ documentation, process descriptions, SOPs and technical reports.
• The ability to assess quality impact, make sound risk‑based decisions and constructively challenge project teams where required.
• Strong communication and stakeholder‑management skills, with the ability to influence effectively across technical and operational functions.
• A proactive, collaborative approach and the ability to operate effectively within a fast‑paced project environment.

Experience within sterile drug product manufacturing, aseptic processing, vial filling or syringe filling is strongly preferred.

Candidates with strong transferable Technology Transfer QA experience from biologics drug substance or other GMP manufacturing environments may also be considered where there is clear evidence of transferable skills and relevant project experience.

Due to the high volume of applications, we may not be able to respond to every applicant.