Specialist Quality Assurance

Amgen UK

Singapore Manufacturing, Singapore
On-site
Gmp compliance requirements
Amgen quality management system
Manufacturing investigations
Amgen is seeking a Specialist Quality Assurance for its Singapore Manufacturing facility, responsible for overseeing quality systems and ensuring compliance with GMP standards. The role involves supporting manufacturing operations, participating in investigations, and collaborating with various teams to maintain product quality

Job Summary

  • Responsible for providing oversight and leadership for quality systems execution and operations support, the Specialist Quality Assurance will support manufacturing operations and IPC testing.
  • Support routine GMP documentation review activities and ensure key performance indicator met targeted metrics.
  • Co-lead and support the deployment of Amgen quality systems, including management review, validation, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations.

Matching Summary

Match Score: 85

Amgen is seeking a Specialist Quality Assurance for its Singapore Manufacturing facility, responsible for overseeing quality systems and ensuring compliance with GMP standards. The role involves supporting manufacturing operations, participating in investigations, and collaborating with various teams to maintain product quality.

Skills & Requirements

Must-have

  • GMP compliance requirements
  • Amgen Quality Management System
  • manufacturing investigations
  • change control
  • unexpected result investigations

Nice-to-have

  • continuous improvement projects
  • supplier quality
  • stability program
  • product quality review
  • customer complaint investigation

Key Requirements

  • 8 years related work experience
  • pharmaceutical / biologics industry experience
  • Direct experience with bulk manufacturing of biopharmaceuticals/API preferred
  • Demonstrated proficiency of written and verbal communication skills
  • Experience with regulatory audits and inspections
  • Problem solving skills

Work Rights

Not specified

Tailored Resume

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