Job Description:
The Quality Assurance (QA) Coordinator plays a pivotal role in ensuring the quality management system (QMS) is fit for purpose, overseeing changes as necessary, and managing communications with regulatory bodies. The ideal candidate will possess strong QA expertise and have a proven track record in managing quality issues to closure.
Key Responsibilities:
* Manage QMS, ensuring it remains effective and compliant.
* Oversee team members in making necessary changes to QMS.
* Approve Standard Operating Procedures (SOPs) and Quality System documents.
* Represent the company during HPRA inspections.
* Support HPRA inspections and prepare written responses.
* Prepare and approve HPRA variations.
* Provide QA expertise and manage quality issues to closure.
* Support internal compliance audits of operations.
* Provide QA oversight for New Product Introductions.
* Review and approve Non-Conformances (NC), CAPA, change controls, and complaints.
* Organize annual supplier reviews.
* Assist in preparing, reviewing, and updating technical agreements with licensees and 3rd party contractors.
* Implement Self Inspection/Internal Quality Audit program.
Requirements:
* Bachelor's degree in Science or equivalent.
* 1 year of relevant experience.
* Ireland work authorization required.
Additional Information:
* Full-time position.
* Yearly bonus available.
* Company pension and sick pay provided.
* Schedule: Monday to Friday.
Estimated Salary:
€60,000 - €80,000 per annum.