Job Title: Quality Assurance Specialist
We are seeking a highly motivated and experienced Quality Assurance Specialist to join our team in Sligo on a 9-month temporary contract with a view to a permanent position.
The ideal candidate will have a proven track record of ensuring products manufactured at the site comply with approved specifications and follow current good manufacturing practice and regulatory agency requirements.
Key Responsibilities:
1. Coordinate Assigned Elements of the Quality System: Ensure full compliance by all relevant plant personnel with its requirements, identifying areas for improvement and implementing corrective actions as needed.
2. Audit the Quality System: Conduct regular audits to ensure the quality system is functioning effectively and make recommendations for improvement.
3. Investigate Customer Complaints: Assist in investigating customer complaints and assessing the need for effective corrective or preventive actions to resolve issues promptly.
4. Manage Day-to-Day CAPA Requirements: Ensure timely and effective initiation, investigation, correction, and corrective actions to minimize disruptions to production.
5. Measure Performance of the Quality System: Provide metrics for inclusion in management reviews, monthly reports, and other key performance indicators to measure the effectiveness of the quality system.
6. Provide Quality Training: Ensure all plant personnel are aware of quality requirements by providing necessary training to maintain a culture of quality excellence.
7. Ensure Regulatory Compliance: Verify the effectiveness of corrective/preventive actions arising from product process and quality system non-compliance and ensure implementation and compliance with relevant Regulator requirements.
8. Participate in Continuous Improvement Programs: Collaborate with cross-functional teams to implement improvements in quality, safety, environmental, and production systems at the site.
9. Complete In-Process and Final Release Product Testing: Perform testing per relevant approved specifications and procedures to ensure products meet required standards.