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

Amgen

Hyderabad, India
On-site
Lead c&q documentation team
Prepare compliant documentation
Partner with cross-functional teams
Lead the preparation and delivery of commissioning and qualification documentation that supports Engineering project execution and GMP manufacturing

Job Summary

  • Lead the preparation and delivery of commissioning and qualification documentation that supports Engineering project execution and GMP manufacturing.
  • Manage work across a blended team of employees and contingent resources, ensuring effective planning, prioritization, and execution of deliverables.
  • Maintain inspection-ready documentation and support regulatory inspections and internal audits as required.

Matching Summary

Lead the preparation and delivery of commissioning and qualification documentation that supports Engineering project execution and GMP manufacturing.

Skills & Requirements

Must-have

  • Lead C&Q documentation team
  • Prepare compliant documentation
  • Partner with cross-functional teams
  • Manage blended team resources
  • Ensure inspection-ready documentation

Nice-to-have

  • Foster culture of accountability
  • Drive continuous improvement initiatives
  • Support regulatory inspections and audits

Key Requirements

  • 8-13 Years of work experience
  • Bachelors or Masters degree
  • Experience in GMP commissioning, qualification, validation, or technical operations
  • Experience preparing C&Q documentation
  • Experience leading technical teams

Work Rights

Not specified

Tailored Resume

Cover Letter