Pharma Analytics Quality Specialist — Dublin (12-Month)

QCS Staffing Ltd; Dublin; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

GMP QC experience

Independent worker

Team collaboration

Regulatory GMP knowledge

Ausbildung

B.A or BSc in Life sciences

Jobbeschreibung

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