Specialist QA

In this role you will be part of Amgen’s Global Supply Quality team supporting oversight and maintenance of contract manufacturers. In the role you will act as a disposition manager ensuring that batch disposition activities are completed in line with Amgen standards.

• →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.

• Deep knowledge of SAP and LIMS systems
• Basic understanding of supply chain and logistics processes.
• Experience with GMP software (Veeva, TrackWise).
• Proficiency in MS Office and comfort with computer-based systems.
• Ability to multitask in a dynamic environment.
• Demonstrated ability to work independently and deliver right first-time results
• Excellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation (eg investigations, procedures, change controls) and good Presentation skills