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QA Specialist

  • Division: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 24415

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 contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706717