Compendial QC Analyst | GMP Quality Control

MSD; Leinster; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Hybrid working model

Job summary

MSD in Ireland is seeking a Quality Control Analyst to join our Dundalk site and contribute to the qualification, testing, and release of drug substances and products.

You will work with cGMP and GLP standards, perform sampling and testing, participate in investigations, and help maintain quality systems, documentation, and training materials. This role requires a science or quality degree, at least two years of lab experience, and strong teamwork and communication.

Qualifications

• Bachelor's degree or equivalent in Science, Quality, or Technical discipline.
• Minimum 2 years' laboratory experience in sampling, testing, and reporting.
• Familiarity with cGMP, GLP, Pharmacopoeias (USP, Ph. Eur.), and Quality Management Systems.
• Ability to work in a team and contribute to Dundalk site operations.

Responsibilities

• Operate as part of the QC team performing allocated testing and lab duties.
• Serve as a testing subject matter expert within the QC department.
• Participate in OOS investigations and support troubleshooting activities.
• Attend daily QC Tier meetings and communicate testing progress, deviations, and any cGMP or compliance concerns.
• Contribute to the drafting, revision, and rollout of SOPs, training materials, and maintenance procedures for quality systems.
• Conduct peer review of testing documentation and ensure data integrity compliance and achievement of QC Right First Time KPIs.
• Support laboratory readiness, audit readiness, and audit participation.
• Assist with laboratory equipment qualification and analytical method transfer, verification, and validation.

Skills

Corrective Action Management

GMP Documentation

GMP Testing

Pharmacopoeias

pH Testing

Quality Control Management

Quality Manuals

Raw Materials

Root Cause Analysis

SOP

Education

Degree in Science/Quality/Technical

Job description

MSD in Ireland is seeking a Quality Control Analyst to join our Dundalk site and contribute to the qualification, testing, and release of drug substances and products.

You will work with cGMP and GLP standards, perform sampling and testing, participate in investigations, and help maintain quality systems, documentation, and training materials. This role requires a science or quality degree, at least two years of lab experience, and strong teamwork and communication.