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 requirements, risk assessments, and validation/CSA deliverables related to digital plant systems.
• Support inspection readiness by ensuring digital processes are defensible, well-governed, and clearly documented.

Required Skills and Experience

• 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 requirements, risk assessments, and validation/CSA deliverables related to digital plant systems.
• Support inspection readiness by ensuring digital processes are defensible, well-governed, and clearly documented.

What do we offer?

• Benefits package (private health insurance, sports card, group insurance).
• Free English lessons with a dedicated teacher.
• Access to an extensive training library covering both soft and technical skills.
• Sports activities.
• Team-building events, contests, and challenges.

Who we are – in a nutshell

Industry: We operate in the IT sector.

Clients: We support international companies in regulated industries (banking, finance, insurance, pharmaceuticals).

Services: We provide comprehensive quality control and implement modern HR platforms for employee management.

How do we work? See what our employees say👉 Piotr i Julia