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QA Digital Manufacturing Lead

Posted 2 days 23 hours ago by Careerwise Recruitment

Permanent

Full Time

Other

Limerick, Limerick, Ireland

Job Description

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 .