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QA Digital Manufacturing Lead
Posted 6 days 3 hours ago by PSC Biotech Corporation
Permanent
Full Time
Other
Limerick, Ireland
Job Description
Job Details 
- Industry: Pharma/Biotech/Clinical Research
- City: Limerick
- State/Province: Limerick
- Country: Ireland
The QA Digital Manufacturing Lead provides QualityAssurance oversight and guidance for the implementation of digitalmanufacturing solutions within a pharma manufacturing environment. The rolefocuses on enabling review by exception (RBE), electronic batch records (eBR),and paperless operations, ensuring compliance with GMP, data integrity, andregulatory expectations while supporting operational efficiency.
Responsibilities- Provide QA leadership and guidance for the design andimplementation 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 withGMP, data integrity principles (ALCOA+), and applicable regulatory requirements(e.g., FDA, EU).
- Partner with Manufacturing, Automation, IT, and Qualityteams to embed quality-by-design into digital workflows.
- Review and approve quality requirements, riskassessments, and validation/CSA deliverables related to digital plant systems.
- Support inspection readiness by ensuring digitalprocesses are defensible, well-governed, and clearly documented.
- Strong QA background in pharmaceutical manufacturingunder GMP.
- Hands-on experience with eBR, DeltaV, MES, or digitalmanufacturing systems.
- Solid understanding of review by exception concepts andpaperless batch release.
- Ability to balance compliance, risk-based thinking, andoperational efficiency.
