Quality Assurance Specialist

Quality Assurance Specialist - Pharmaceutical Industry

Drive quality excellence at a premier biotech facility.

Join a dynamic team at our state-of-the-art site in Carlow, Ireland-a key manufacturing center producing critical pharmaceutical products during an exciting expansion phase. As a Quality Assurance Specialist, you'll safeguard compliance and operational excellence across drug manufacturing operations. Reporting to the QA Manager, leverage your expertise for batch release, audits, and continuous improvement in a high-impact role.

Key Benefits of the Role

• Collaborative culture: Work with high-performing teams prioritizing safety, cGMP compliance, and innovation.
• Strategic impact: Support global supply of essential medicines from cutting-edge facilities.

Core Responsibilities

• Ensure cGMP compliance in manufacturing, testing, and documentation processes.
• Review batch records, deviations, and change controls for data integrity and First Time Right KPIs.
• Lead or support internal and external audits and inspections as subject matter expert or auditee.
• Participate in daily QA Tier meetings to monitor progress, resolve issues, and ensure site readiness.
• Develop, revise, and train on SOPs, quality procedures, and risk assessments such as FMEA and root cause analysis.
• Handle OOS/CAPA investigations and continuous improvement using tools like 5 Whys and Fishbone diagrams.
• Build a proactive, compliant quality culture through cross-functional collaboration.

Qualifications We Value

• Bachelor's degree or higher (ideally in Life Sciences, Pharmacy, or related field).
• 2-3 years in pharmaceutical QA, with cGMP experience in manufacturing environments.
• Strong knowledge of Quality Management Systems, LIMS, and regulatory standards (FDA, EMA).
• Desired experience: batch review/release, audit experience, deviation management, and validation support.

Applicants should apply directly on our website for this role.