Senior QC Analytical Specialist – GMP & Method Transfer

Atrium; Dublin; Presencial; EUR 70 000 - 90 000; Tempo integral

Resumo da oferta

Atrium is hiring a Senior Quality Specialist – Analytical QC in Dublin to strengthen analytical oversight across Raw Starting Materials, Intermediates, API and Drug Product in an external manufacturing environment. You will provide expert analytical troubleshooting and collaborate with CMOs/CTLs and internal teams.

The role emphasizes GMP compliance, problem-solving, and QA leadership with responsibility for investigations, method transfer, and regulatory submissions.

Qualificações

• 3–5+ years' experience within a GMP pharmaceutical QC environment.
• BSc/BA in Life Sciences, Chemistry, Pharmacy or related.
• Strong GMP knowledge and QA systems.
• Experience with RSM, Intermediates, API and/or Drug Product testing.
• Excellent stakeholder and project management skills.
• Experience with CMOs, CTLs or third-party laboratories is advantageous.

Responsabilidades

• Provide analytical expertise and troubleshooting for pharmaceutical testing.
• Coordinate analytical testing performed by CMOs and contract laboratories.
• Review and approve laboratory investigations, deviations and OOS events.
• Lead investigations into analytical deviations and ensure corrective actions.
• Review and support analytical change controls.
• Support analytical method validation, verification and technical transfer.
• Ensure GMP, ICH and regulatory requirements are met in all activities.
• Support stability programmes, sample testing and laboratory documentation.
• Act as QC laboratory SME during internal and external audits.
• Work with Quality, Manufacturing, Regulatory and global stakeholders.
• Support analytical components of regulatory submissions.

Conhecimentos

Analytical troubleshooting

Stakeholder management

Project management

GMP knowledge

Quality systems

Formação académica

BSc/BA in Life Sciences, Chemistry, Pharmacy or related

Descrição da oferta de emprego

Atrium is hiring a Senior Quality Specialist – Analytical QC in Dublin to strengthen analytical oversight across Raw Starting Materials, Intermediates, API and Drug Product in an external manufacturing environment. You will provide expert analytical troubleshooting and collaborate with CMOs/CTLs and internal teams.

The role emphasizes GMP compliance, problem-solving, and QA leadership with responsibility for investigations, method transfer, and regulatory submissions.