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Quality Assurance Specialist

Job description

Quality Specialist
Co. Tipperary | Pharmaceutical

We are currently seeking an experienced Quality Specialist – Quality Systems for a leading pharmaceutical facility in Co. Tipperary, supporting both Drug Substance and Drug Product operations. This is a key role within the Quality Systems Team, ensuring compliance with GMP standards and supporting critical quality and validation functions across the site.

Key Responsibilities:

  • Act as SME for validation (process, cleaning, equipment, water) and change control.

  • Provide QA oversight for laboratory systems, incidents, and microbiology.

  • Manage Quality Agreements, Annual Product Reviews, and Quality Council coordination.

  • Review regulatory data, site licences, and support audits/inspections.

  • Lead and participate in continuous improvement and cross-functional quality initiatives.

Requirements:

  • Strong experience in GMP and pharmaceutical quality systems.

  • In-depth knowledge of validation, change control, and regulatory compliance.

  • Excellent documentation, communication, and analytical problem-solving skills.

  • Proficiency with systems such as SAP, GLIMS, and Microsoft Office.

This is a fantastic opportunity to join a high-performing quality team in a global pharma company committed to excellence in manufacturing and compliance. To apply, email your CV to rachel.ginnell@forcerecruitment.com