This role provides direct Quality support to the Upstream production area as part of a Quality IPT (Integrated Product Team)
Job Summary
This role provides direct Quality support to the Upstream production area as part of a Quality IPT (Integrated Product Team).
The Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor.
The Biotech facility in Dublin plays a pivotal role in the manufacture of biologics-based medicines including immuno-oncology, with full manufacturing operations since 2021.
Matching Summary
This role provides direct Quality support to the Upstream production area as part of a Quality IPT (Integrated Product Team).
Skills & Requirements
Must-have
GMP Manufacturing Compliance
Quality Operations in Biotech
Production Documentation Review
Shop Floor Quality Support
Change Management and CAPA
Regulatory Compliance Support
Nice-to-have
Strong Interpersonal Skills
Leadership and Communication
Problem Solving and Critical Thinking
Cross-functional Collaboration
Continuous Improvement Initiatives
Key Requirements
Bachelor’s degree in scientific or engineering field or relevant experience
Minimum 5 years GMP Manufacturing or QA experience
At least 2 years biotech industry QA operations experience