We are seeking an experienced Quality Manager to oversee quality operations at a manufacturing facility based in Tullamore, Co. Offaly. This role is ideal for a proactive and detail-oriented individual with a background in quality assurance, ideally within the pharmaceutical or graphics industry.
Key Responsibilities:
1. Lead and manage site quality documentation and quality systems.
2. Provide support to the production department on quality-related topics.
3. Oversee and approve production batches (delegated to Quality Control).
4. Manage internal and external deviations and CAPA plans.
5. Conduct risk assessments and drive continuous improvement projects.
6. Lead process validations and change management activities.
7. Execute internal and supplier audits; participate in third-party audits.
8. Monitor and report on KPIs; analyse data and implement improvement actions.
9. Train other departments on quality procedures and tools.
10. Oversee measuring instruments management.
Key Criteria:
11. Minimum 3 years' experience in a Quality role, preferably within GMP, pharmaceutical, or graphic industries.
12. Third level quality-related degree or relevant to the relevant industries above.
13. Knowledge of ISO 9001, GMP requirements, ISO 19011.
14. Experience with risk analysis, CAPA, and documentation systems.
15. Lean Manufacturing, 8D reporting, and project management are preferred.
16. Proficiency in Microsoft Word, Excel, email platforms, and ERP systems.