Specialist Quality Assurance

About the role

Amgen Singapore Manufacturing is seeking a Specialist Quality Assurance to provide oversight and leadership for quality systems across plant operations. The role involves on‑site support for manufacturing and IPC testing, as well as handling complex investigations, change control, and regulatory interactions.

Key responsibilities

• Provide quality oversight to plant operations, ensuring GMP and cGMP compliance throughout commissioning, qualification, and market supply phases.
• Review routine GMP documentation such as electronic batch records, SOPs, logbooks, work orders, and validation protocols.
• Co‑lead deployment of quality systems, including management review, validation, change control, and CAPA.
• Participate in and review complex root‑cause investigations, deviation investigations, and change controls.
• Support New Product Introduction (NPI) teams and coach site QA professionals on complex problem resolution.
• Engage with regulatory inspectors during inspections and support continuous‑improvement, supplier quality, stability, product quality review, and customer complaint investigations.

Required profile

• Doctorate, Master’s (with 2 years experience), Bachelor’s (with 4 years experience) or Diploma (with 8 years experience) in a relevant field.
• Minimum 8 years of experience in pharmaceutical/biologics manufacturing, process development, or quality assurance with progressive responsibility.
• Direct experience with bulk manufacturing of biopharmaceuticals/API preferred.
• Strong written and verbal communication skills.

Required skills

• GMP and cGMP compliance
• CAPA management
• Validation and change control processes
• Root‑cause investigation methodology
• Electronic batch record systems
• Documentation review (SOPs, batch records, validation protocols)

What we offer

• Opportunity to work in a leading global biotechnology company.
• Exposure to cutting‑edge biopharmaceutical manufacturing.
• Collaborative environment with professional development support.