The Role
Coordinate QA resources assigned to functional areas to meet business objectives.
Key Responsibilities:
* Quality Management System (QMS): Ensure the QMS is fit for purpose, oversee team members in making necessary changes, approve SOPs and Quality System documents.
* HPRA Inspection: Manage communications with and represent the company during HPRA inspections.
* Support and Preparation: Support HPRA inspections, assist with written responses, prepare and approve variations.
* QA Expertise: Provide QA expertise, manage quality issues to closure, support internal compliance audits.
* New Product Introductions: Oversee QA oversight and expertise for NPIs, review and approval of Non-Conformances (NC), CAPA, change controls, and complaints.
* Supplier Review: Organize annual supplier reviews.
* Tech Agreements: Assist in preparation, review, and update of technical agreements with licensees and 3rd party contractors.
* Internal Audit: Organize periodic review of QMS and operational procedures for regulatory compliance through internal audit systems.
* Self Inspection: Implement the Self Inspection/Internal Quality Audit program.
* Issue Escalation: Overall responsibility for reporting and investigation of non-conformances, identification of CAPAs, and escalation of issues as appropriate.
* Cross Functional Teams: Participate in cross-functional teams as Quality representative, provide advice and direction to other departments on quality and regulatory issues.
Requirements
* BSc (Hons) in Science or equivalent.
* 1 year of relevant experience.
* Ireland work authorization.
* Full-time schedule (Monday to Friday).