Senior Quality Specialist

3 weeks ago


Dublin, Dublin City, Ireland West Pharmaceutical Services Full time
Join our Team at West

At West, we are a team with a mission to enhance patient lives, a legacy that spans over a century. Starting with Herman O. West's breakthrough in supplying penicillin during World War 2, we have been delivering life-saving medicines to millions daily, shaping the healthcare industry. Now, we invite you to be part of this legacy and help write our future.

Join our inclusive community of professionals at West, where you can grow and learn throughout your career. We prioritize the well-being of our team members and their families, offering support for physical, mental, emotional, and financial health.

Our commitment extends to giving back to communities in need, as well as fostering a sustainable environment for a healthier planet.

Summary:

As a Senior Quality Specialist, you will oversee our Quality Management Systems, focusing on customer needs and driving continuous improvements. Collaborate with various departments to ensure compliance and maintain quality standards. This role involves mentoring, coordinating quality projects, and ensuring adherence to regulatory requirements.

Requirements:
  • Third level qualification in Engineering/Quality/Science
  • 5+ years' experience in Medical Device or Pharmaceutical Manufacturing
  • Knowledge of ISO 13485 / 21 CFR Part 820 / 21 CFR Part 4/ EU GMP
  • Experience in quality risk management and regulatory audits
  • Strong communication skills and ability to work in a fast-paced environment
  • Detail-oriented, self-motivated, and able to prioritize tasks efficiently
Essential Duties and Responsibilities:
  • Ensure compliance with internal procedures and global regulatory requirements
  • Lead investigations on Quality System issues
  • Support trend analysis and respond to Competent Authority queries
  • Drive improvements in data integrity and compliance culture
  • Coordinate Quality Systems KPI reporting and support regulatory submissions

When absent, duties will be delegated to designated roles in the Quality team. Join us at West, where your skills will make a difference in patient care and quality assurance.



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