QA Specialist

Collins McNicholas Recruitment; Athlone Municipal District; On-site; EUR 45,000 - 65,000; Full time

Job summary

A leading pharmaceutical manufacturer in Sligo is seeking a QA Specialist to ensure compliance with GMP standards in a full-time, onsite role. The successful candidate will manage quality systems, provide technical guidance, and support continuous improvement initiatives within a dynamic team environment.

Qualifications

• Minimum of 5 years’ experience in a GMP-regulated Quality environment.
• Experience in a Validation role with knowledge of project lifecycle and GMP regulations.

Responsibilities

• Serve as the site QA point of contact for compliance matters.
• Manage the Quality Management System to align with regulatory standards.
• Conduct timely reviews and approvals of QA documentation.

Skills

GMP compliance

Attention to detail

Technical writing

Time management

Communication

Teamwork

Education

Third-level qualification in a relevant science or engineering discipline

Job description

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 of QA Specialist in Sligo, please contactMichelle Mc Inerney.

[e-mail]

091 706717