23300-QA Specialist – Tipperary Contractor

QA Specialist

Purpose

The Quality Specialist participates as a member of the Quality Systems Team. Quality Systems supports the Quality Systems activities in the both the Drug Substance and Drug Product facilities on site.

Responsibilities

 Quality Systems Ownership

• Own and manage designated quality subsystems as outlined in the site System Ownership framework.
• Create, review, and approve essential quality documentation, including Site Master Files, Validation Master Plans, policies, and procedures.

 Subject Matter Expert (SME) Responsibilities

• Serve as Quality SME for process validation, cleaning validation, water systems, equipment qualification, and change control.
• Participate in validation and qualification governance groups and provide technical and compliance oversight.
• Approve validation documentation and ensure ongoing compliance following system or process changes.
• Provide validation input and support for capital and improvement projects.
• Develop validation summary reports and contribute to quality planning for key initiatives.

 Laboratory QA Oversight

• Provide QA oversight for laboratory systems, including instruments, data systems, and investigations.
• Review and approve stability reports and data for intermediates and final products.
• Act as the QA point of contact for microbiological quality, including water systems, utilities, environments, excipients, and products.

Quality Agreement & Change Control Management

• Maintain and manage the site inventory of Quality Agreements, ensuring completeness, accuracy, and retrievability.
• Serve as the primary QA reviewer for change requests that impact processing and analytical systems, ensuring full compliance with site procedures.

 Regulatory & Licence Compliance

• Support product filings and ongoing maintenance of site licences and regulatory documentation.
• Review and verify quality data used in regulatory submissions to ensure accuracy and data integrity.

 Annual Review & Audit Support

• Manage the Annual Product/Process Quality Review system, ensuring reviews are completed on time and meet internal requirements.
• Support internal audits, routine GMP inspections, and external regulatory inspections.

 Governance & Quality Council Activities

• Manage scheduling, agenda preparation, minute-taking, and action tracking for site Quality Council meetings.
• Provide oversight of application user access reviews to ensure compliance with procedural requirements.

 Supplier & Customer Quality Support

• Review Supplier Change Evaluation documentation and support related system updates.
• Investigate and review internal and external customer and supplier complaints within agreed timeframes.
• Support the generation and review of technical/quality agreements with suppliers when required.

Qualifications

• Bachelor’s degree or higher in Science, Pharmacy, or Engineering.
• Prior experience in a GMP-regulated pharmaceutical or biopharma environment.
• Working knowledge of validation, change control, and quality systems.
• Familiarity with laboratory quality oversight and regulatory documentation.
• Strong written and verbal communication skills.
• Proficient in Microsoft Office and quality management systems.
• Ability to work cross-functionally and manage multiple priorities.