Quality Assurance Specialist — Hybrid Role

Msd Ireland; Ireland; Hybrid; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

MSD Ireland at the Ballydine site is seeking a Quality Specialist to support day-to-day QA activities and join the Process IPT. You will review batch documentation, manage deviations and CAPAs, and drive continuous improvement in quality systems.

The role requires GMP knowledge, a science/pharmacy degree, and experience with QA processes. A hybrid work model and opportunity to work on key quality initiatives are offered.

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Experience with GMP requirements and quality systems in manufacturing.
• Knowledge of quality IT systems such as SAP or Trackwise is desirable.

Responsibilities

• Participate as functional expert in cross-functional team managing production right first time on site.
• Review and approve batch, cleaning and testing documentation.
• Document, assess and drive CAPAs for OOS and deviations.
• Support deviation investigations and process performance monitoring with trending.
• Provide guidance on quality requirements to maintain validation status and risk assessments.
• Contribute to annual process and system reviews and lead internal GMP walkdowns.
• Create, review and approve quality procedures; communicate quality metrics.

Skills

Aseptic Manufacturing

QA Documentation

GMP Compliance

CAPA Management

Quality Metrics

Risk Assessment

Education

Science/Pharmacy degree

Tools

SAP

Trackwise

Job description

MSD Ireland at the Ballydine site is seeking a Quality Specialist to support day-to-day QA activities and join the Process IPT. You will review batch documentation, manage deviations and CAPAs, and drive continuous improvement in quality systems.

The role requires GMP knowledge, a science/pharmacy degree, and experience with QA processes. A hybrid work model and opportunity to work on key quality initiatives are offered.