Quality Assurance Specialist: Process & Compliance Lead

Merck; Ireland; On-site; EUR 65,000 - 90,000; Full time

Job summary

Merck Ballydine, Ireland, seeks a Quality Specialist to support day‑to‑day QA activities on site and drive continuous improvement within the Process IPT. You will review batch and testing docs, manage deviations, CAPAs, and participate in audits while applying GMP standards across the facility.

Ideal candidates hold a science or pharmacy degree with experience in GMP, quality systems, and IT tools such as SAP and Trackwise; strong communication and teamwork are essential.

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
• Experience in GMP environments and deviation investigation is preferred.
• Familiarity with CAPA management and change controls is advantageous.

Responsibilities

• Participate as functional expert in cross-functional team that manages production right first time at site.
• Review and approve batch, cleaning and testing documentation.
• Ensure all OOS and process deviations are documented and CAPA identified.
• Provide support to deviation investigations and process performance monitoring.
• Lead quality system reviews and participate in audits; communicate quality metrics.

Skills

Aseptic Manufacturing

Audits Compliance

CAPA Management

Change Controls

GMP Compliance

Process Improvements

Quality Assurance Tools

Quality Auditing

Quality Management Systems

Education

Degree in Science or Pharmacy

Tools

SAP

Trackwise

Job description

Merck Ballydine, Ireland, seeks a Quality Specialist to support day‑to‑day QA activities on site and drive continuous improvement within the Process IPT. You will review batch and testing docs, manage deviations, CAPAs, and participate in audits while applying GMP standards across the facility.

Ideal candidates hold a science or pharmacy degree with experience in GMP, quality systems, and IT tools such as SAP and Trackwise; strong communication and teamwork are essential.