Job Opportunity
We are seeking a Quality Assurance Specialist to join our team on a permanent, full-time basis.
This role will play a key part in ensuring compliance with GMP and regulatory standards while supporting the qualification and validation of manufacturing operations.
Responsibilities
1. Serve as the site QA point of contact, providing technical expertise, feedback, and guidance on QA and compliance matters.
2. Manage assigned areas of the Quality Management System (QMS) to ensure product manufacturing aligns with GMP and regulatory standards.
3. 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.
4. Generate, review, and approve SOPs and other documentation related to areas of responsibility.
5. Conduct timely review and approval of site procedures and documentation to ensure alignment with GMP and regulatory requirements.
6. Review and approve validation protocols, reports, and associated documentation to ensure compliance with EU regulatory standards and internal procedures.
7. Maintain documentation schedules to support technology transfers and new product introduction timelines.
8. Apply Quality Risk Management principles to all applicable activities.
9. Act as QA lead on cross-functional project teams involving Operations, Quality Control, Engineering, and other departments.
Requirements
1. Strong understanding of GMP compliance and quality standards.
2. Excellent attention to detail with significant experience in document review.
3. Proficient in technical writing, including deviation reports and SOPs.
4. Strong time management and multitasking abilities.
5. Demonstrated ability to drive task completion, resolve issues, and maintain high-quality standards.
6. Excellent communication skills, both verbal and written.
7. Proficient in written and spoken English.
8. Strong team player with a collaborative mindset.
9. Third-level qualification in a relevant science or engineering discipline.
10. Minimum of 5 years' experience in a GMP-regulated Quality environment.
11. Experience in a Validation role with solid knowledge of the project lifecycle and current GMP regulations.