Quality Systems Specialist

Merck Sharp & Dohme Corp

Dublin, Ireland
Hybrid
Change control management experience
Internal auditing capabilities
Cgmp compliance execution
The Quality Systems Specialist is responsible for maintaining and continuously improving the quality management system to ensure compliance, safety, and reliable supply

Job Summary

  • The Quality Systems Specialist is responsible for maintaining and continuously improving the quality management system to ensure compliance, safety, and reliable supply.
  • This role involves managing change controls, conducting internal audits, and supporting regulatory inspections while fostering a culture of Right First Time delivery.
  • Candidates must possess excellent communication skills and a desire to continuously learn within a high-performing team dedicated to patient-centric healthcare solutions.

Matching Summary

The Quality Systems Specialist is responsible for maintaining and continuously improving the quality management system to ensure compliance, safety, and reliable supply.

Skills & Requirements

Must-have

  • Change control management experience
  • Internal auditing capabilities
  • cGMP compliance execution
  • Deviation trending analysis
  • Quality Management System maintenance

Nice-to-have

  • New product introduction experience
  • Process qualification knowledge
  • Technology transfer background
  • Inspiring team leadership style
  • Continuous improvement mindset

Key Requirements

  • Bachelor or Master's degree in Biological Sciences
  • 5 years' experience in Quality Control or Assurance
  • Pharmaceutical or Biologics operations experience

Work Rights

Not specified

Tailored Resume

Cover Letter