Quality - Senior Specialist

Atrium; Dublin; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Analytical troubleshooting

Stakeholder management

Project management

GMP knowledge

Quality systems

Formation

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

Description du poste

Atrium is currently recruiting for a Senior Quality Specialist – Analytical QC to join a leading global pharmaceutical organisation in Dublin.

This is an excellent opportunity for an experienced QC / Analytical professional to support pharmaceutical testing activities across Raw Starting Materials (RSM), Intermediates, API and Drug Products within an external manufacturing environment.

You will work closely with Contract Manufacturing Organisations (CMOs), Contract Testing Laboratories (CTLs) and internal cross-functional teams, providing analytical expertise, troubleshooting support and oversight of testing and quality activities.

Key Responsibilities

• Provide analytical expertise and troubleshooting support for pharmaceutical testing activities.
• Coordinate analytical testing performed by CMOs and contract testing laboratories.
• Review and approve laboratory investigations, deviations and OOS events.
• Lead investigations into significant analytical deviations and ensure appropriate corrective actions.
• Review and support analytical change controls.
• Support analytical method validation, verification and technical transfer activities.
• Ensure analytical activities are performed in accordance with GMP, ICH and applicable regulatory requirements.
• Support stability programmes, sample testing and laboratory documentation.
• Act as a QC laboratory subject matter expert during internal and external audits.
• Work closely with Quality, Manufacturing, Regulatory and other global stakeholders.
• Support APQRs, risk assessments, quality agreements and analytical components of regulatory submissions.

We are looking for someone with:

• BSc/BA in Life Sciences, Chemistry, Pharmacy or a related discipline.
• 3–5+ years' experience within a GMP pharmaceutical QC environment.
• Strong operational experience within a pharmaceutical QC laboratory.
• Experience with RSM, Intermediate, API and/or Drug Product testing.
• Good knowledge of OOS, deviations and laboratory investigations.
• Strong understanding of GMP and pharmaceutical Quality Management Systems.
• Knowledge of analytical method validation, verification and/or technical transfer.
• Strong analytical troubleshooting and problem-solving abilities.
• Excellent stakeholder and project management skills.
• Experience working with CMOs, CTLs or other third-party laboratories would be highly advantageous.