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.