Quality Assurance Specialist (Operations)
Sligo
Perm role - Hybrid
We are seeking a detail-oriented Quality Assurance Specialist for our Operations function to ensure products are manufactured in compliance with GMP and regulatory standards. You will provide quality support to operations, focusing on reviewing batch documentation, managing investigations, approving changes, and driving process improvements. This role requires collaboration with departments like Quality Control, Manufacturing, and Engineering.
KEY RESPONSIBILITIES:
- Oversee QMS areas: Deviation Investigations, Change Control, and CAPA systems.
- Review/approve Manufacturing Batch Records and production materials.
- Provide QA expertise for manufacturing, validations, and new product introductions.
- Manage assigned QMS areas, ensuring compliance with GMP and regulations.
- Generate and approve SOPs and related documentation.
- Support continuous improvement initiatives and cross-functional teams.
REQUIREMENTS:
- Bachelor's degree in a relevant science or engineering field.
- 5+ years in a GMP Quality environment.
- Strong knowledge of QMS, batch documentation, and root cause investigations.
- Excellent attention to detail, technical writing, and problem-solving skills.
- Strong communication and collaboration abilities.
Contact me today for further information.