QA Digital Manufacturing Lead

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...