Job Description
A QA Digital Manufacturing Lead (contractor position) is required by Careerwise recruitment to work with a Limerick based Pharmaceutical company. 12 months contract.
Role of this position
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 d...