About this role
The Specialist Quality Assurance provides leadership and oversight for quality systems, ensuring manufacturing operations and IPC testing comply with GMP requirements. They are responsible for managing complex investigations, change controls, and supporting new product introductions within the plant.
Candidates must possess a degree (Doctorate, Master's, Bachelor's, or Diploma) with at least 8 years of relevant experience in the pharmaceutical or biologics industry. Strong proficiency in quality systems, project management, and regulatory inspection processes is required.
What they're looking for
Quality AssuranceGMP complianceManufacturing operationsRoot cause investigationChange controlCAPAValidationProject management
Frequently asked questions
What does a Specialist Quality Assurance (API) at Amgen do?
The Specialist Quality Assurance provides leadership and oversight for quality systems, ensuring manufacturing operations and IPC testing comply with GMP requirements. They are responsible for managing complex investigations, change controls, and supporting new product introductions within the plant…
What skills does this Specialist Quality Assurance (API) role need?
Key skills for this role include Quality Assurance, GMP compliance, Manufacturing operations, Root cause investigation, Change control, CAPA.
How much does a Specialist Quality Assurance (API) at Amgen pay?
The employer did not list a salary for this role. Most similar Singapore roles publish their band on the job page.
Is this Specialist Quality Assurance (API) role remote, hybrid, or on-site?
This role is on-site, based in Singapore.
How do I apply for this Specialist Quality Assurance (API) role?
You can apply directly on Amgen's careers page. ApplyLah can tailor your résumé and cover letter to this exact role in seconds first.