QUALITY RISK MANAGEMENT LEAD with extensive QRM experience in GMP-regulated pharmaceutical or biologics manufacturing environment required by CareerWise Recruitment for a DIGITAL CORE IMPLEMENTATION project with our Life Sciences client in Limerick.
➡️ Initial 12 month contract on offer with site presence required 5 days per week on-site.
➡️ This role sits within the Quality Assurance group.
➡️ QRM experience in GMP-regulated pharmaceutical or biologics manufacturing environment.
➡️ Strong knowledge of ICH Q9(R1), digital manufacturing and system-enabled operations.
➡️ Experience addressing operational resiliency, data integrity and business continuity in digital or paperless environments.
NOTE: No sponsorship is provided for this role so applicants need to already have Irish / EU citizenship OR the relevant Stamp / Visa in place.
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 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.
Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@careerwise.ie
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.