Quality Assurance Specialist (Technical Support)

About the role

Amgen is hiring a Specialist Quality Assurance (Technical Support) for its Biologics and Synthetic Manufacturing plants in Singapore. The role provides oversight and leadership for quality systems execution and operations support to Facilities & Engineering, Quality Control, Technology, Process Development and Validation (non-manufacturing areas), covering commissioning, qualification, regulatory approval and market supply.

Key responsibilities

• Provide quality oversight of plant operations, ensuring GMP compliance and the Amgen Quality Management System are applied correctly during commissioning, qualification, regulatory approval and market supply.
• Support routine GMP documentation review (SOPs, logbooks, work orders, validation documents, periodic reviews) and ensure key performance indicators meet targets.
• Co-lead and support quality systems such as management review, validation, deviation, change control and CAPA, in line with cGMP expectations.
• Review and approve deviations, investigations, testing results, change controls and other quality records, and lead complex root cause investigations.
• Lead QA oversight in commissioning, qualification and new product introduction projects, and coach site QA professionals on resolving quality issues.
• Take part in regulatory inspections and interact directly with inspectors, and lead or support continuous improvement initiatives.

Required profile

• Doctorate, or Master's degree with 2 years of experience in a pharmaceutical company or GMP environment, or Bachelor's degree with 4 years of experience in such an environment, or Diploma with 8 years of experience.
• Preferred: 8 years of related experience in manufacturing, process development or quality assurance in the pharmaceutical/biologics industry, with project management, quality assurance and quality systems experience.
• Demonstrated direct experience with bulk manufacturing of biopharmaceuticals/API preferred.
• Experience with regulatory audits and inspections.
• Strong written and verbal communication, including technical writing and presentations, and stakeholder management.
• Problem-solving skills and logical assessment of data for compliance and product quality decisions.
• Selection is subject to meeting the medical requirements of the role.