Specialist Qc I

Amgen UK

Dun Laoghaire, Ireland
Cgmp quality control laboratory
Laboratory systems qualification
Computerised maintenance management system (cmms)
Responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities

Job Summary

  • Responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities.
  • Responsible for authoring/owning and approving Validation Life Cycle documents for computer related systems including responsibility for Data Integrity testing and business administration of Laboratory Computer Related systems.
  • The Specialist will act as senior member of the technical services team and will contribute to team training and mentoring.

Matching Summary

Responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities.

Skills & Requirements

Must-have

  • cGMP Quality Control laboratory
  • laboratory systems qualification
  • Computerised Maintenance Management System (CMMS)
  • Data Integrity testing
  • analytical instrument validation
  • cGXP laboratory equipment validation

Nice-to-have

  • continuous improvement culture
  • senior member of technical services
  • team training and mentoring

Key Requirements

  • Bachelor’s degree in a Science related field
  • 5+ years of laboratory experience
  • exposure to analytical instrument validation

Work Rights

Not specified

Tailored Resume

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