eConsulting Sp. z o.o.→
QRM Lead– Digital Core implementation at eConsulting… · Limerick
Mid LevelOn-siteContractLimerick, County Limerick, IE
Skills
quality risk managementich q9digital manufacturing conceptssystem-enabled operationsdcsmesebrerpdata historiansnetwork infrastructurebusiness continuity planninggmp compliancestrategic thinkinginfluencecollaborationrisk assessment
Job Description
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.
Benefits
Private health insurance
Sports card
Group insurance
Free English lessons
Access to training library
Sports activities
Team-building events