34434-QA Specialist-Dublin Contractor

This is a 12-month initial contract.

Purpose

We are seeking an experienced QA Specialist to join our Quality Assurance team. This senior role requires expertise in quality systems, compliance, and risk management within a pharmaceutical or biotechnology environment. The ideal candidate will ensure adherence to regulatory standards, drive continuous improvement, and provide subject matter expertise in key quality processes.

Responsibilities

• Oversee and maintain site quality systems, including Documentation Management, Change Control, Deviation/CAPA, and Quality Management Review.
• Provide Quality direction at Change Control and Deviation Review Boards, ensuring timely and robust implementation.
• Manage Quality Agreements and stay updated onregulatory guidelines to ensure compliance.
• LeadQuality Risk Management (QRM)initiatives and embed QRM principles into the quality framework.
• Analyze trend data (Deviations, CAPA, Change Control) to optimize quality programs and compliance.
• Support Regulatory inspections and ensure readiness for audits.

Requirements

• Bachelor’s degree in Engineering, Science, or related field.
• 8+ years of experience in pharmaceutical/biotech QA, with expertise in aseptic operations, protein formulation, or sterile filling.
• Strong knowledge of GMP, FDA/EMA regulations, and experience with Regulatory inspections.
• Proven skills in Root Cause Analysis, Deviation investigations, and cross-functional collaboration.
• Excellent communication, organizational, and problem-solving abilities.