QA Lead, Tech Transfer & NPI - Pharma

PE Global; Dún Laoghaire-Rathdown; On-site; EUR 83,000 - 120,000; Full time

Job summary

PE Global is currently recruiting a Quality Assurance Specialist – Tech Transfer/ NPI for a leading multinational Pharma client based in South Dublin. This is a contract position and the successful candidate will lead QA activities across technology transfer and new product introduction projects.

You will provide QA oversight from initial transfer planning through PPQ readiness, validation, and regulatory readiness, collaborating with Process Development, Engineering, Manufacturing, and

Qualifications

• Bachelor’s or Master’s degree in Science, Engineering, Biotechnology, or related discipline.
• 8+ years’ experience in pharmaceutical or biotechnology manufacturing.
• 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.
• Good understanding of change control, deviation/CAPA, risk assessment and validation lifecycle requirements.
• Experience reviewing or approving batch records, validation protocols/reports, PPQ documentation, process descriptions, SOPs and technical reports.
• Ability to assess quality impact, challenge project teams where required and make risk-based QA decisions.
• Strong communication skills and ability to build effective working relationships with stakeholders.
• Sterile drug product, aseptic manufacturing, vial or syringe filling experience strongly preferred; transferable QA experience from biologics or other GMP environments considered.

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.
• Assess deviations, CAPAs, change controls and technical risks prior to PPQ or commercial manufacture.
• Ensure batch record, recipe, BOM, sampling and testing readiness are appropriately controlled for transferred products.
• Partner cross-functionally with Process Development, Engineering, Manufacturing, Validation, QC and Regulatory teams to ensure NPI and transfer activities are compliant with site quality requirements.
• Support regulatory filing and commercial readiness activities related to product transfers.
• Provide QA review and approval of validation and operational readiness documentation associated with new product introductions and line transfers.
• 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.
• 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.
• Ensure risks are appropriately documented and controlled.
• Act as a proactive QA partner to project teams, ensuring issues are identified early and resolved through compliant, risk-based decision-making.

Skills

QA leadership

Technology Transfer

NPI

Change control

Process validation

PPQ readiness

Regulatory compliance

Audit readiness

Cross-functional collaboration

GMP

Education

Bachelor's or Master's degree in Science/Engineering/Biotechnology

Job description

PE Global is currently recruiting a Quality Assurance Specialist – Tech Transfer/ NPI for a leading multinational Pharma client based in South Dublin. This is a contract position and the successful candidate will lead QA activities across technology transfer and new product introduction projects.

You will provide QA oversight from initial transfer planning through PPQ readiness, validation, and regulatory readiness, collaborating with Process Development, Engineering, Manufacturing, and