Analytical Quality Specialist

QCS Staffing Ltd; Dublin; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

Analytical Quality Specialist role based in Dublin, Ireland, on an initial 12-month contract within a leading life sciences organization. You will provide analytical expertise and troubleshooting support for external manufacturing environments, engaging with stakeholders to plan testing at CMOs and CTLs.

The ideal candidate has extensive GMP QC experience and a Life Sciences degree, with working knowledge of FDA/EU GMP requirements and familiarity with Quality Management Systems in laboratory

Qualifications

• Extensive experience in GMP QC environment.
• Bachelor's degree in Life sciences or equivalent.
• Knowledge of FDA & EU GMP requirements.
• Understanding of Quality Management Systems in laboratory operations.

Responsabilités

• Provide analytical expertise and troubleshooting support in Pharma for external manufacturing.
• Coordinate testing of Pharma products at contract testing laboratories and CMOs with internal/external stakeholders.
• Serve as analytical contact for CMOs and CTLs and address analytical issues with stakeholders.
• Review and approve laboratory investigations, deviations, and OOS events with method SMEs.
• Provide technical support to the QP/RP and Quality Operations.

Connaissances

GMP QC experience

Independent worker

Team collaboration

Regulatory GMP knowledge

Formation

B.A or BSc in Life sciences

Description du poste

Analytical Quality Specialist – Dublin, Ireland – Initial 12-Month Contract – Life Sciences

Are you an Analytical Quality Specialist looking for your next assignment in Dublin? A leading multinational in Ireland’s thriving biopharma industry requires support for their major facility development. This project provides hands‑on experience with innovative equipment, large‑scale operations and modern pharmaceutical technologies. It’s an ideal opportunity to build your skills within one of Europe’s fastest‑growing life‑science regions.

What you’ll do:

• Provision of analytical expertise and troubleshooting support in the areas of Pharma for the external manufacturing environment
• Engage with internal and external stakeholders to plan and manage all testing of Pharma products at contract testing laboratories and CMOs
• Serve as analytical contact for CMOs and CTLs (associated with ExM), addressing analytical issues and requests while coordinating with relevant stakeholders
• Review and approve laboratory investigations, deviations, and out-of-specification (OOS) events at CMOs and CTLs in partnership with method subject matter experts.
• Provide technical support to the Qualified Person (QP)/ Responsible Person (RP) and Quality Operations in relation to same

What you’ll need:

• Extensive experience in GMP QC environment
• Minimum B.A or BSc in Life sciences
• Ability to work independently and within team matrix environments
• Thorough knowledge of worldwide regulatory Good Manufacturing Practices (GMP) requirements and a working knowledge of Food and Drug Administration (FDA) & European Union (EU) GMP requirements
• In depth knowledge of Quality Management Systems relating to laboratory operations