QA Digital Manufacturing Lead

A QA Digital Manufacturing Lead (contractor position) for a 12 month contract with a Limerick based pharmaceutical company.

Responsibilities include:

• Provide QA leadership and guidance for the design and implementation of electronic Batch Release (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.

Qualifications and Requirements

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

Contact: Please call Michael O'Connor today for further information at or email .