Specialist Quality Assurance

About the role

Amgen Singapore Manufacturing is looking for a Specialist Quality Assurance to act as a Subject Matter Expert and site representative for the Quality Management System (QMS) within the Amgen Network. The role covers assigned QMS areas such as deviations, CAPA and change control, and acts as site project lead when there are system updates or rollouts.

Key responsibilities

• Manage the implementation of process changes and ensure consistent execution of quality processes at the site
• Monitor performance of quality processes and communicate it to Global Process Owners, users and management
• Communicate the impact of process changes to management and users
• Attend network and collaboration group meetings, representing site challenges, lessons learned, audit and inspection findings and best practices
• Review global standards and author or contribute to QA process documentation, training materials and onboarding of new users
• Escalate performance issues and trends to Global Process Owners and management
• Ensure inspection readiness and alignment of local procedures with QMS requirements, and represent the process during audits and regulatory inspections
• Own site-specific commitments, and may lead process improvement projects and own deviations, CAPA/EVs and change records

Required profile

• Doctorate, or Master's degree with 2 years of directly related experience, or Bachelor's degree with 4 years, or Diploma with 8 years of directly related experience
• 8 years of work experience in manufacturing, process development or quality assurance in the pharmaceutical/biologics industry, with progressive responsibility
• Demonstrated experience in project management, quality assurance and quality systems
• Direct experience with bulk manufacturing of biopharmaceuticals/API preferred
• Experience with regulatory audits and inspections
• Medical requirements of the job scope must be fulfilled

Required skills

• Proficiency in written and verbal communication, including technical writing and presentations
• Problem-solving and data assessment for compliance and product quality decisions