Quality Specialist – Quality Management System #25581
RK25581
Contract 11 months
Dublin


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in 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.



This role will be responsible for supporting the Quality Department. Ensure that objectives are effectively achieved, consistent with the company requirements to ensure compliance, safety and reliable supply to our customers



Key Responsibilities:

• Internal and external inspection and auditing, change control management, quality systems management, GMP training & knowledge management.
• Supporting the management of the site Documentation / SOP management systems
• Provides compliance contribution to project teams and leads specific projects.
• Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
• Responds to non-standard requests from customer needs.
• Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
• Use standard systems including MS Word, Excel, PowerPoint, Outlook, SAP and various company and industry specific software such as document tracking, work order entry/tracking, procurement, manufacturing entry/reporting, etc.
• Presentation, compilation and review of data as directed
• Provide quality support to the site, including training and guidance on the interpretation and implementation of Our Company’s Guidelines / Policies and regulatory requirements

• Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or equivalent
• A minimum of 3-4 years experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations
• Knowledge of EU/US quality related pharmaceutical regulations
• Excellent knowledge of relevant Quality and GMP Compliance Guideline