QA Specialist (REMOTE)
RK4397
12 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.



In this role you will be part of the Global Supply Quality team supporting oversight and maintenance of contract manufacturers.



Duties:

• Act as disposition manager ensuring that batch disposition activities are completed in line with company standards
• Manage and drive Quality records to closure including deviation records, investigation reports
• Initiate Quality records for supplier related changes.
• Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed
• Provide data to the networks to support Quality Management Processes)
• Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Take part in operational and quality improvement initiatives, programs, and projects.
• Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs.

• 4+ years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.
• Good working knowledge of SAP
• Experience in investigations, project management and trending and analysis
• Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing.
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).