Specialist, Quality Systems And Compliance

Merck Sharp & Dohme Corp

Dunboyne, Meath, Ireland
**
Bachelor's degree in life science
3+ years fda/ema regulated experience
Sap master data build and maintenance
** Merck Sharp & Dohme Corp is seeking a Specialist in Quality Systems and Compliance to join their R&D facility in Dunboyne, Ireland. The position focuses on supporting quality management systems, compliance activities, and cross-functional collaboration to ensure adherence to regulatory standards. **

Job Summary

  • This role supports the Global Development Quality Assurance team at the Merck R&D facility in Dunboyne.
  • The specialist will manage quality systems activities including documentation, auditing, deviation management, and change control.
  • Candidates must have strong knowledge of SAP usage and previous experience in QRM, SQM, and regulatory compliance.

Matching Summary

Match Score: 75

** Merck Sharp & Dohme Corp is seeking a Specialist in Quality Systems and Compliance to join their R&D facility in Dunboyne, Ireland. The position focuses on supporting quality management systems, compliance activities, and cross-functional collaboration to ensure adherence to regulatory standards. **

Skills & Requirements

Must-have

  • Bachelor's degree in Life Science
  • 3+ years FDA/EMA regulated experience
  • SAP master data build and maintenance
  • QMS development and maintenance experience
  • Knowledge of Veeva, Delta-V, TrackWise, PAS-X

Nice-to-have

  • Strong attention to detail and precision
  • Ability to think logically under pressure
  • Experience with supplier/vendor qualification
  • Proactive problem-solving skills
  • Collaborative cross-functional teamwork

Key Requirements

  • Bachelor's degree or higher in Life Science
  • Minimum 3 years experience in pharmaceutical industry
  • Experience with GMP documentation review
  • Knowledge of Health Authority Guidelines for Biologics

Work Rights

Not specified

Tailored Resume

Cover Letter