This role provides direct Quality support to the Upstream production area as part of a Quality IPT (Integrated Product Team) at a biotech facility in Dublin
Job Summary
This role provides direct Quality support to the Upstream production area as part of a Quality IPT (Integrated Product Team) at a biotech facility in Dublin.
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 position involves participation in continuous improvement initiatives to enhance operational efficiency and resolve issues, supporting sustaining activities, audits, and regulatory inspections.
Matching Summary
This role provides direct Quality support to the Upstream production area as part of a Quality IPT (Integrated Product Team) at a biotech facility in Dublin.
Skills & Requirements
Must-have
Quality Assurance Operations
Good Manufacturing Practices (GMP)
Batch Record Review and Approval
Compliance and Data Integrity
Quality Support for Capital Projects
Cross-functional Team Collaboration
Nice-to-have
Leadership and Mentorship Skills
Problem Solving and Critical Thinking
Bioprocessing Knowledge
Continuous Improvement Initiatives
Strong Oral and Written Communication
Key Requirements
Bachelor’s degree in scientific or engineering field or relevant experience
Minimum 5 years GMP Manufacturing or Quality Assurance experience
At least 2 years biotech industry QA operations experience