Systems Improvement Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeQuality Full time €60,000 - €90,000

Role Overview

We are seeking a Quality Systems Specialist to join our team. This role will be responsible for developing and implementing site quality systems to support the manufacture and release of combination products.

  • Develop and implement site quality systems to support the manufacture and release of combination products, including SOPs, document control, change control, investigations, CAPA, internal auditing, vendor qualification & management, material and batch disposition, complaints and annual product review.
  • Provide QA support to ensure inspection readiness.
  • Collaborate with key stakeholders, including engineering, validation, manufacturing, regulatory, and global quality.
  • Support the operation of the site training system, including preparing and presenting relevant training materials as required.
  • Ensure compliance with appropriate regulatory guidance documents while driving improvements in product and process quality.
  • Support the implementation of the continuous improvement program by identifying, leading, and implementing improvements.
  • Comply with company and legislative environment, health, and safety requirements.
Key Responsibilities
  • Develop and implement site quality systems.
  • Provide QA support.
  • Collaborate with key stakeholders.
  • Support the operation of the site training system.
  • Ensure compliance with regulatory requirements.
  • Support the implementation of the continuous improvement program.

Requirements:

  • Education to degree level with proven industry experience.
  • Working knowledge of EU & US regulatory requirements.
  • Experience in designing and implementing quality systems or start-up an advantage.
  • High proficiency in Microsoft Word/Excel/PowerPoint/MS Project etc.
  • Proficiency in electronic systems/databases such as documentation, Trackwise, SAP etc.
  • Good team working and strong communication skills across functions and organization.
Benefits

We offer competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to make an impact on the lives of others.

Opportunities for career progression and work-life balance initiatives.

A diverse and inclusive workplace culture.

Why Viatris?

We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life.

Our mission is to create healthier communities worldwide through education, outreach, and better access to treatment.

Join us in making a difference in the world.

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