Quality Systems Specialist
Life Science Recruitment
- Dublin Swords, Co Dublin
- Contract
- Full-time
AMC21195
Contract – 11 months
SwordsWe’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.
- 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.
- 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.