QRM Lead– Digital Core implementation

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...

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