Position Overview
Workplace: on-site (Limerick)
Workload: Full-time
Type of Contract: B2B
Key Responsibilities
- Provide QA leadership and guidance for the design and implementation of eBR and paperless
manufacturing processes.
- Define and approve review by exception (RBE) strategies, including deviation thresholds, exception
handling, and QA review models.
- Ensure digital manufacturing solutions are aligned with GMP, data integrity principles (ALCOA+), and
applicable regulatory requirements (e.g., FDA, EU).
- Partner with Manufacturing, Automation, IT, and Quality teams to embed quality-by-design into digital
workflows.
- Review and approve quality require...