Job Opportunity: QA Specialist
Overview
Seeking a highly skilled and experienced Quality Assurance Specialist to join our team in Sligo. This permanent, full-time role offers a collaborative and dynamic work environment where you can make a meaningful contribution to the quality of our products.
Key Responsibilities
* Serve as the site Quality Assurance point of contact, providing technical expertise, feedback, and guidance on Quality Assurance and compliance matters, including validation strategies, new product introductions, and manufacturing-related issues, commensurate with the level of risk.
* Manage assigned areas of the Quality Management System (QMS) to ensure product manufacturing aligns with regulatory standards.
* Oversee QMS elements including deviations, change control, CAPA, internal/external audits, customer complaints, vendor management, and the review and approval of manufacturing batch records and production materials.
* Generate, review, and approve SOPs and other documentation related to areas of responsibility.
* Conduct timely review and approval of site procedures and documentation to ensure alignment with regulatory requirements.
* Review and approve validation protocols, reports, and associated documentation to ensure compliance with EU regulatory standards and internal procedures.
* Maintain documentation schedules to support technology transfers and new product introduction timelines.
* Apply Quality Risk Management principles to all applicable activities.
* Act as Quality lead on cross-functional project teams involving Operations, Quality Control, Engineering, and other departments.
* Actively contribute to site-wide continuous improvement initiatives.
Requirements
* Strong understanding of GMP compliance and quality standards.
* Excellent attention to detail with significant experience in document review.
* Proficient in technical writing, including deviation reports and SOPs.
* Strong time management and multitasking abilities.
* Demonstrated ability to drive task completion, resolve issues, and maintain high-quality standards.
* Excellent communication skills, both verbal and written.
* Proficient in written and spoken English.
* Strong team player with a collaborative mindset.
* Third-level qualification in a relevant science or engineering discipline.
* Minimum of 5 years' experience in a GMP-regulated Quality environment.
* Experience in a Validation role with solid knowledge of the project lifecycle and current GMP regulations.
For more information please contact 071 91 08062