Contract
QA QRM Lead
Posted on 14 October 26 by Geraldine Gormally
- Limerick, Limerick
- €0 - €0 per Annum
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Job Description
QRM Lead – Digital Core ImplementationDepartment: Quality Assurance
Hybrid - 3 days onsite
Summary:
The QRM Lead will establish and embed a risk-based quality management program for a new digitally
enabled biologics manufacturing facility. As the project QRM subject-matter expert, they will ensure that
quality risk management is systematically applied across facility start-up, operational resilience, digital
system dependency, and paperless manufacturing continuity.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Establish and manage the facility QRM program in accordance with applicable regulations, ICH
Q9(R1) and internal procedures.
• Select appropriate risk assessment methods and facilitate the completion, periodic review and
communication of risk assessments.
• Embed risk-based decision-making across facility start-up, manufacturing, automation, data flows
and quality oversight.
• Ensure risk decisions are science-based, documented and inspection-ready.
• Partner with Quality, Manufacturing, IT, Automation and Engineering to identify, mitigate and
assign ownership of risks.
• Develop and maintain the risk management plan for digital and corporate systems, including
DCS, MES, eBR, ERP, data historians and network infrastructure.
• Support project quality and business objectives relating to GxP risk management.
Education and experience:
• Extensive QRM experience in GMP-regulated pharmaceutical or biologics manufacturing,
including use of multiple risk assessment methods and facilitation of complex risk assessments.
• Strong knowledge of ICH Q9(R1), digital manufacturing and system-enabled operations.
• Demonstrated ability to influence site design, operating models and quality governance.
• Experience managing operational resilience, data integrity and business continuity risks in digital
or paperless environmentss.