Manager, Commissioning & Qualification (c&q) Document Preparation - Drug Substance

Amgen Australia Pty Ltd

Gmp commissioning and qualification experience
C&q documentation protocol and report preparation
Leading blended teams of employees and contingent workers
This role leads a blended team responsible for preparing compliant, inspection-ready commissioning and qualification documentation

Job Summary

  • This role leads a blended team responsible for preparing compliant, inspection-ready commissioning and qualification documentation.
  • The position ensures documentation is delivered with high quality and aligned with project timelines across Amgen's operations.
  • Candidates must have strong understanding of risk-based qualification methodologies and lifecycle validation approaches in a regulated environment.

Matching Summary

This role leads a blended team responsible for preparing compliant, inspection-ready commissioning and qualification documentation.

Skills & Requirements

Must-have

  • GMP commissioning and qualification experience
  • C&Q documentation protocol and report preparation
  • Leading blended teams of employees and contingent workers
  • Risk-based qualification methodologies
  • Lifecycle validation approaches

Nice-to-have

  • Strong project management and organizational skills
  • Excellent written and verbal communication abilities
  • Experience with regulatory inspections and audits
  • Continuous improvement initiative contributions
  • Collaboration across multiple engineering departments

Key Requirements

  • Bachelors or Masters degree required
  • 8-13 years of work experience in relevant field
  • Experience in GMP commissioning, qualification, or validation
  • Experience leading technical teams including contingent resources

Work Rights

Not specified

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