QA Digital Manufacturing Lead

eConsulting; Limerick; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Private health insurance

Sports card

Group insurance

Free English lessons

Job summary

eConsulting in Ireland is seeking a QA leader to guide the design and implementation of eBR and paperless manufacturing processes, ensuring compliance with GMP and data integrity standards.

You will collaborate with Manufacturing, IT, Automation and Quality teams to embed quality-by-design into digital workflows, review QA deliverables, and support inspection readiness with well-governed, defensible processes.

Qualifications

• Provide QA leadership for eBR and paperless manufacturing processes.
• Define and approve review by exception (RBE) strategies and QA review models.
• Ensure digital manufacturing aligns with GMP and data integrity principles (ALCOA+).
• Partner with Manufacturing, Automation, IT, and Quality to embed QbD into digital workflows.
• Review and approve QA requirements, risk assessments, and validation/CSA deliverables.

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 (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.

Skills

QA leadership

GMP compliance

Regulatory awareness

Quality-by-design

Stakeholder liaison

Education

Bachelor's degree in a relevant field

Tools

ALCOA+

Quality management systems

Job description

Workplace: on-site (Limerick)

Workload: Full-time

Type of Contract: B2B

• 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.

Key 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 (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.

Required Skills And Experience

• 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.

What do we offer?

• Benefits package (private health insurance, sports card, group insurance).
• Free English lessons with a dedicated teacher.
• Access to an extensive training library covering both soft and technical skills.
• Sports activities.
• Team-building events, contests, and challenges.

Who We Are – In a Nutshell

Industry: We operate in the IT sector.

Clients: We support international companies in regulated industries (banking, finance, insurance, pharmaceuticals).

Services: We provide comprehensive quality control and implement modern HR platforms for employee management.

How do we work? See what our employees say Piotr i Julia