Associate Scientist – GMP & Change Control, Dublin

QCS Staffing Ltd; Ireland; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

QCS Staffing Ltd is seeking an Associate Scientist for a 12-month contract in Dublin, Ireland, supporting a leading multinational in the biopharma sector.

You will deliver analytical change controls, author and review change control processes in the eQMS, monitor timelines, and support analytical method transfers and validations in GMP QC labs. A strong background in biological/chemical sciences and pharma quality/compliance is required.

Qualifikationen

• Bachelor's degree in Biological Sciences, Chemistry or a related discipline.
• Extensive experience in Quality and Compliance organizations.
• Advanced degree (MS/PhD) in a science or pharmaceutical-field.
• Extensive experience in a pharmaceutical/biotech environment, with exposure to Change control.

Aufgaben

• Own and/or support analytical change controls for changes to global test methods or regulatory filings.
• Author, review, and manage change control processes within the electronic Quality Management System (eQMS).
• Track change control timelines, ensure on-time closure, and escalate delays to management.
• Own and/or support analytical method transfers and validations in GMP QC labs with protocol generation, reporting, and leadership updates.

Kenntnisse

Change control

eQMS

Analytical method transfers

GMP QC

Regulatory filings

Ausbildung

Bachelor's degree in Biological Sciences or Chemistry

MS/PhD in a science or pharmaceutical field

Experience in pharma/biotech environment

Jobbeschreibung

QCS Staffing Ltd is seeking an Associate Scientist for a 12-month contract in Dublin, Ireland, supporting a leading multinational in the biopharma sector.

You will deliver analytical change controls, author and review change control processes in the eQMS, monitor timelines, and support analytical method transfers and validations in GMP QC labs. A strong background in biological/chemical sciences and pharma quality/compliance is required.