Senior Commissioning And Qualification Specialist

alvotech.is

Gmp commissioning and qualification
Qualification documentation generation and execution
Regulatory compliance eu and us
Lead GMP commissioning and qualification activities for facilities, utilities, and equipment

Job Summary

  • Lead GMP commissioning and qualification activities for facilities, utilities, and equipment.
  • Generate, execute, review, and approve qualification documentation including URS, IQ/OQ/PQ protocols, validation plans, and summary reports.
  • Collaborate with cross-functional teams including QA, Engineering, Automation, and Project Management to drive quality and innovation.

Matching Summary

Lead GMP commissioning and qualification activities for facilities, utilities, and equipment.

Skills & Requirements

Must-have

  • GMP commissioning and qualification
  • qualification documentation generation and execution
  • regulatory compliance EU and US
  • biopharmaceutical manufacturing systems

Nice-to-have

  • cross-functional team collaboration
  • mentoring junior colleagues
  • proactive and organized approach
  • fast-paced environment adaptability

Key Requirements

  • Technical degree or higher
  • Strong understanding of GMP regulations
  • Experience with discrepancy/deviation handling

Work Rights

Not specified

Tailored Resume

Cover Letter