QA Specialist
- Dublin
- Contract
- Full-time
- Act as disposition manager ensuring that batch disposition activities are completed in line with Amgen 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.
- Minimum of 4 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.
- Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them
- Previous experience in batch release activities
- Good working knowledge of SAP
- Experience in investigations, project management and trending and analysis a benefit.
- 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).
- Proven experience in designing and/or improving processes at conceptual level
- Desire to partner with internal and external stakeholders across teams
- Understanding of industry requirements/expectations of a robust Quality Management System and documentation.