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Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

Quality Systems Specialist


Reference:AMC21195 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Quality Systems Specialist

Quality Systems Specialist
AMC21195
Contract – 11 months
Swords

We’re currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in North Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Job Purpose:

The Quality Systems Specialist plays a vital role in maintaining and enhancing the company’s Quality Management System, ensuring alignment with company requirements to uphold compliance, safety, and consistent supply to customers.

Primary Responsibilities:

  • Provide quality support to projects and sites, offering training and guidance on the interpretation and implementation of company Guidelines/Policies and regulatory standards.
  • Specialize in deviation management, change control management, quality systems management, document/SOP management, and GMP training & knowledge management.
  • Ensure the health and effectiveness of the Quality Management system at the site, taking timely actions to meet compliance and production requirements.
  • Assist in metrics management for site deviation and change control systems.
  • Review and approve site deviation and investigation reports.
  • Support the site change management process.
  • Identify root causes of deviations and implement corrective actions, demonstrating basic knowledge of six sigma, LEAN, and root cause analysis tools.
  • Manage day-to-day Deviation CAPA and Change Control metrics.
  • Oversee the quarterly deviation trending process and annual trending at the site.
  • Collaborate with cross-functional departments to meet change control and deviation management system requirements.
  • Assist in Regulatory and Compliance Inspections at the site as necessary.
  • Support recall management activities.
  • Adhere to company Global and regulatory requirements, executing current Good Manufacturing Practices (cGMP) in all applicable job functions.
  • Foster a Quality culture focused on delivering uninterrupted supply and Right First Time service to patients.
Qualifications and Experience:

Minimum Education/Experience:
  • Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering, or equivalent.
  • 5 years’ experience in Quality Control, Quality Assurance, Pharmaceutical, Vaccine, or Biological Operations, or Technical Operations.
Technical Skills:
  • Proficient knowledge of relevant Quality and Compliance Guidelines (cGMP, Auditing, Quality Management Systems, Quality Agreements, Regulatory Affairs, Training) and associated regulations.
  • Experience with new product introductions and/or process qualification/technology transfer.

If you're passionate about quality and compliance and thrive in a collaborative, fast-paced environment, we'd love to hear from you! Please feel free to contact Angela McCauley on +353 (0)87 693 0951 or [email protected] for further information.