Workplace: on-site (Limerick)
Workload: Full-time
Type of Contract: B2B
Key Responsibilities
- Design and implement a modern, facility-wide Quality Risk Management (QRM) framework, aligned
with ICH Q9(R1), supporting a fully digital plant. - Embed risk-based thinking into all aspects of facility startup, including manufacturing processes, digital
systems, automation, data flows, and quality oversight. - Assess and manage risks related to dependency on digital and corporate systems, including DCS, MES,
eBR, ERP, data historians, and network infrastructure. - Define and govern business continuity and contingency strategies to ensure GMP compliance during
system outages (e.g., network failures, cloud unavailability), including controlled fallback for paperless
operations. - Partner with Quality, Manufacturing, IT, Automation, and Engineering to ensure risks are proactively
identified, mitigated, and owned. - Ensure risk decisions are science-based, documented, and inspection-ready, supporting regulatory
confidence in a highly digital operating model.
Required Skills and Experience
- At least 5 years of experience in Quality Risk Management within GMP-regulated pharma or biologics
manufacturing. - Strong knowledge of ICH Q9, digital manufacturing concepts, and system-enabled operations.
- Proven ability to operate at a strategic level, influencing site design, operating models, and quality
governance. - Experience addressing operational resiliency, data integrity, and business continuity in digital or
paperless environments.
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