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QA Quality Risk Management Lead
- Limerick, Wexford, Ireland
- Limerick, Wexford, Ireland
Über
If you are considering sending an application, make sure to hit the apply button below after reading through the entire description.
The role ensures that quality risk management is systematically applied across processes, systems, and operations, with particular focus on operational resiliency, digital system dependency, and paperless manufacturing continuity.
Essential Duties and Responsibilities include, but are not limited to, the following: 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.
Education and experience: Extensive 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. xyswxtq
Experience addressing operational resiliency, data integrity, and business continuity in digital or paperless environments.
Skills: ICH Q9 Digital and Corporate Systems DCS-MES-eBR-ERP
TPBN1_IJ
Sprachkenntnisse
- English
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