QA Digital Manufacturing Lead
Confidential
- Limerick, Wexford, Ireland
- Limerick, Wexford, Ireland
Über
If your skills, experience, and qualifications match those in this job overview, do not delay your application.
The role focuses on enabling review by exception (RBE), electronic batch records (eBR), and paperless operations, ensuring compliance with GMP, data integrity, and regulatory expectations while supporting operational efficiency.
Essential Duties and Responsibilities include, but are not limited to, the following: ? 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.
Education and experience: ? 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.
? xyswxtq Ability to balance compliance, risk-based thinking, and operational efficiency.
TPBN1_IJ
Sprachkenntnisse
- English
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