My client, a leading pharmaceutical manufacturer based in Sligo, is seeking to hire a QA Specialist on a permanent, full-time basis. This is a fully onsite role offering the opportunity to work in a collaborative and dynamic environment. The successful candidate will play a key role in Quality Assurance activities supporting the qualification and validation of manufacturing operations, while ensuring compliance with GMP and regulatory standards.
Responsibilities:
- Serve as the site QA point of contact, providing technical expertise, feedback, and guidance on QA and compliance matters, including validation strategies, new product introductions, and manufacturing-related issues, commensurate with the level of risk.
- Manage assigned areas of the Quality Management System (QMS) to ensure product manufacturing aligns with GMP and regulatory standards.
- 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.
- Generate, review, and approve SOPs and other documentation related to areas of responsibility.
- Conduct timely review and approval of site procedures and documentation to ensure alignment with GMP and regulatory requirements.
- Review and approve validation protocols, reports, and associated documentation to ensure compliance with EU regulatory standards and internal procedures.
- Maintain documentation schedules to support technology transfers and new product introduction timelines.
- Apply Quality Risk Management principles to all applicable activities.
- Act as QA lead on cross-functional project teams involving Operations, Quality Control, Engineering, and other departments.
- Actively contribute to site-wide continuous improvement initiatives.
Requirements:
- Strong understanding of GMP compliance and quality standards.
- Excellent attention to detail with significant experience in document review.
- Proficient in technical writing, including deviation reports and SOPs.
- Strong time management and multitasking abilities.
- Demonstrated ability to drive task completion, resolve issues, and maintain high-quality standards.
- Excellent communication skills, both verbal and written.
- Proficient in written and spoken English.
- Strong team player with a collaborative mindset.
- Third-level qualification in a relevant science or engineering discipline.
- Minimum of 5 years’ experience in a GMP-regulated Quality environment.
- Experience in a Validation role with solid knowledge of the project lifecycle and current GMP regulations.
For more information and a confidential discussion on the role please contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
071 91 08062