THE ROLE:
1. Coordinating QA resources assigned to functional area to meet goals.
2. Manage the QMS, ensuring it is fit for purpose, overseeing the team in making changes as necessary, and approving SOPs and Quality System documents.
3. Manage communications with and represent the company during HPRA Inspection.
4. Support HPRA inspections and assist with the preparation of written responses to inspections.
5. Prepare and approve HPRA variations.
6. Provide QA expertise and manage any Quality issues that arise to closure.
7. Support internal compliance audits of operations.
8. Provide QA oversight and expertise for New Product Introductions.
9. Oversee the team in the review and approval of Non-Conformances (NC), CAPA, change controls, and complaints.
10. Organise annual review of suppliers.
11. Assist in the preparation, review, and regular update of technical agreements with licensees and 3rd party contractors.
12. Organise and schedule periodic review of QMS and operational procedures for regulatory compliance through internal audit system.
13. Implementation of the Self Inspection/Internal Quality Audit program.
14. Overall responsibility for reporting and investigation of non-conformances and identification of CAPAs to ensure continuous improvement of the QMS and operational procedures.
15. Escalation of issues as appropriate.
16. Participating in cross-functional teams as Quality representative.
17. Providing advice and direction to other company departments on quality and regulatory issues.
REQUIREMENTS:
1. BSc (Hons) in Science or equivalent.
2. Relevant experience: 1 year (required).
3. Work authorisation: Ireland (required).
Job Type: Full-time
Additional pay:
* Yearly bonus.
Benefits:
* Company pension.
* On-site parking.
* Sick pay.
Schedule:
* Monday to Friday.
* No weekends.
Work Location: In person (ideally).
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