QUALIFICATIONS

• Doctorate degree in Science OR
• Master’s degree and 2 years of directly related experience OR
• Bachelor’s degree and 4 years of directly related experience OR
• Diploma and 8 years of directly related experience
• Preferred 8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical / biologics industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and regulated quality systems.
• Direct experience with bulk manufacturing of biopharmaceuticals/API preferred.
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.
• Experience with regulatory audits and inspections
• Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.

WHAT YOU WILL DO

Responsible for ensuring compliance with regulatory requirements at the site level. This role involves managing inspection and audit readiness, execution, and outcomes, as well as coordinating with various stakeholders to support inspection processes. The Specialist Quality Assurance will support activities in both the Biologics and/or Synthetic Manufacturing plants.

Main Responsibilities:

• Lead and support GMP agency and third-party inspections/audits
• Responsible for Internal and Global Quality Compliance auditing program and execution
• Manage inspection logistics, including communication with inspectors, establish inspection team, identifying site/network SME support, inspection package, logistic support for inspectors/ auditors, inspection room set up
• Maintain Site Inspection Readiness
• Conduct training for inspection SMEs and support staff on inspection fundamentals, cultural awareness, and logistics.
• Execute and track Inspection Commitment Applicability Assessments
• Follow up on Site Inspection Commitments to ensure timely closure and adequacy
• Provide quality oversight to plant operations, ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System
• Be a Subject Matter Expert (SME) and site representative for Amgen Singapore Manufacturing in Amgen Network for the specified Quality Management System. In case of any system update, new system rollout act as the site project lead.
• Purposefully monitors execution of the specified quality processes and communicates performance and trends to Global Process Owners/Users & Management reviews, applicable SMEs and site/functional/regional management
• Understands process changes and communicates impact to management/users
• Coach site Quality Assurance professionals on resolution of complex problems
• Supporting other Quality Assurance initiatives/activities such as continuous improvement projects, supplier quality, stability program and product quality review.