The quality assurance team is responsible for ensuring that our products meet the highest standards of quality. This role involves leading, managing and developing a small team to maintain and improve our Quality Management System (QMS) to meet ISO and cGMP standards.
Key Responsibilities
1. Lead the Quality Assurance Team: Oversee the day-to-day activities of the QA team and provide guidance and support to ensure they have the necessary skills and resources to perform their duties effectively.
2. Maintain QMS: Develop, implement and maintain procedures to ensure compliance with regulatory requirements and industry standards.
3. Audit and Compliance: Conduct internal audits to evaluate the effectiveness of our QMS and identify areas for improvement. Ensure that all processes and procedures are compliant with relevant regulations and industry standards.
4. CAPA Systems: Implement and manage corrective action systems to address any deviations or non-compliances identified during audits or other quality-related activities.
5. New Product Development: Provide quality oversight on equipment qualification, process validation and risk management to ensure new products meet quality and safety standards.
6. Continuous Improvement: Drive continuous improvement initiatives using Lean tools to optimize quality processes and reduce compliance risk.
Required Skills and Qualifications
* 5+ years experience in QA management within a regulated manufacturing industry
* Strong working knowledge of ISO and GMP and related quality systems
* Demonstrated experience with audits, CAPAs, change control and validation protocols
* Strong communication and cross-functional collaboration skills
* ASQ Certification or Six Sigma (Green/Black Belt) is a plus
Benefits
* Mobile phone allowance
* Paid holidays
* Canteen facilities
* Parking facilities
* VHI pension scheme
* Educational assistance