Job Title: Quality Assurance Administrator
We are seeking a highly skilled Quality Assurance Administrator for a permanent role in Galway. Our client, a leader in the pharmaceutical and medical device sector, is committed to delivering high-quality products while adhering to ISO 13485 standards.
Roles and Responsibilities:
* Perform routine particulate counting and environmental monitoring in controlled environments.
* Conduct calibration, maintenance, and equipment verification, ensuring all instruments function correctly and within specifications.
* Support the implementation and maintenance of the Quality Management System (QMS) to ensure compliance with ISO 13485 standards.
* Assist with supplier management activities, including supplier qualification, monitoring, and periodic revaluation to ensure compliance with regulatory and company standards.
* Review and maintain supplier documentation, such as certificates of analysis, quality agreements, and audit reports.
* Collaborate with suppliers to address quality issues and ensure timely implementation of corrective and preventive actions (CAPA).
* Assist in preparing and executing internal and external audits, ensuring accurate documentation.
* Document, investigate, and support the resolution of non-conformances, deviations, and complaints.
* Conduct sampling and testing of raw materials, in-process materials, and finished products.
* Maintain accurate records of quality-related data, test results, calibration activities, and supplier performance metrics.
* Assist in creating, reviewing, and revising quality documentation, including procedures, forms, and work instructions.
* Monitor and maintain cleanliness and compliance in controlled environments, adhering to established protocols.
* Participate in root cause analysis and support CAPA implementation.
Qualifications & Professional Skills:
* Bachelor's degree or diploma in Quality Assurance, Engineering, Life Sciences, or a related field.
* 1+ years experience in quality or a related discipline preferred.
* Strong attention to detail with excellent verbal and written communication skills.
* Understanding of customer quality and delivery requirements.
* Ability to impart knowledge clearly and concisely.
* Strong teamwork skills with a results-driven mindset.
* Strong decision-making and reporting abilities.