QA Digital Manufacturing Lead

PSC Biotech Corporation; Limerick; On-site; EUR 70,000 - 90,000; Full time

Job summary

PSC Biotech Corporation is seeking a QA Digital Manufacturing Lead in Limerick, Ireland. This role involves providing Quality Assurance oversight for digital manufacturing solutions within a pharmaceutical environment. Responsibilities include ensuring compliance with GMP standards and enabling efficient digital workflows through collaboration.

The ideal candidate will have a strong QA background with hands-on experience in eBR and digital systems, along with a thorough understanding of regulatory requirements.

Qualifications

• 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.

Responsibilities

• 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, and applicable regulatory requirements.

Skills

Quality Assurance (QA)

Digital Manufacturing Systems

Risk Assessment

Regulatory Compliance (GMP, FDA, EU)

Tools

eBR Systems

DeltaV

Manufacturing Execution Systems (MES)

Job description

Job Details

• Industry: Pharma/Biotech/Clinical Research
• City: Limerick
• State/Province: Limerick
• Country: Ireland

Job Description

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.

Qualifications

• 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.