QA Digital Manufacturing Lead

QA Digital Manufacturing Lead - Ireland, Limerick - 12 Month Contract

Ireland is a hive of activity for the Life Sciences Sector at present with global players setting up new and expanding existing manufacturing facilities all over the World. An exciting opportunity has arisen to work for a global pharmaceutical organisation on a major expansion project based in the picturesque Limerick.

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)
• Review and approve quality requirements, risk assessments, and validation/CSA deliverables related to digital plant systems

Qualifications

• Strong QA background in pharmaceutical manufacturing under GMP
• Hands on experience with eBR, DeltaV, MES, or digital manufacturing systems
• Solid understanding of review by exception concepts and paperless batch release
• Ability to balance compliance, risk based thinking, and operational efficiency