QA Digital Manufacturing Lead

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

THE ROLE:

• 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.

REQUIREMENTS:

• 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.

Please call Michael O’Connor today for further information on 091-452410 or email moconnor@careerwise.ie

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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