Quality Assurance Specialist required for an established Pharma related manufacturing company in Laois. Our client offers a full range of products to the pharma/bio pharma and biotech sector in Ireland. Reporting directly to the QA Supervisor, the QA Specialist will support the Quality Management System, ensuring compliance with established procedures and quality/business requirements. Knowledge of current regulatory requirements and working knowledge of ISO 9001:2015 essential.
Role
1. Responsible for managing day-to-day activities to ensure compliance to the established Quality Management System.
2. Supporting product realization in a GMP environment.
3. Managing, updating, and communicating monthly metrics.
4. Implementing revised quality metrics.
5. Managing the Corrective and Preventative action (CAPA) and deviation processes.
6. Co-ordinating deviation investigations.
7. Supporting SME’s in addressing findings.
8. Mentoring Quality Assurance associates.
9. Manage internal Audit program.
10. Leading monthly quality audits of each area.
11. Ensuring controlled areas operate to the required standards.
12. Actively participate and implement continuous improvement initiatives.
13. Provide support and expertise for inspection readiness.
14. Update internal procedures as appropriate.
15. Support customer and regulatory audits.
16. Support projects as required.
17. Providing regular updates to the Quality Supervisor.
Requirements
1. Bachelor's Degree in a Science Related Discipline.
2. Min 6 years’ experience in a Pharmaceutical GMP environment, desirable.
3. Good knowledge of current regulatory requirements and working knowledge of ISO 9001:2015 is required.
4. Knowledge of EXCiPACT and IPEC regulations an advantage.
5. Experience in Quality Risk management.
6. Desired competencies include strong attention to detail focused on delivery of a Quality product.
7. Good organizational and presentation skills, ability to communicate Quality Metrics to management.
8. Strong interpersonal and communication skills, ability to maintain positive, Quality focused relationships with internal and external stakeholders.
9. Excellent written and oral communication skills.
10. Strong leadership and conflict resolution skills.
11. Ability to foster collaborative, cross-department relationships to meet common objectives.
For more information, please reach out to aisling.murray@cpl.ie.
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