QA Digital Manufacturing Lead

Project overview

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

JOB REQUIREMENTS

Please call Michael O’Connor today for further information on [contact removed] or email [contact removed]

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. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities.

CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

• 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.
• 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.

Project details

• Start: flexible
• Location: Limerick, IE