Senior Specialist, Quality Control

539

Equipment qualification in gmp environment
Computerized systems validation experience
Laboratory system lifecycle management
The role ensures all materials are manufactured, processed, and tested in alignment with high quality standards and regulatory requirements

Job Summary

  • The role ensures all materials are manufactured, processed, and tested in alignment with high quality standards and regulatory requirements.
  • You will lead laboratory system lifecycle management including risk-based qualification, commissioning, and periodic reviews for computerized systems.
  • As a Subject-Matter-Expert, you will provide expert guidance to team members and act as a backup to the Reporting Manager.

Matching Summary

The role ensures all materials are manufactured, processed, and tested in alignment with high quality standards and regulatory requirements.

Skills & Requirements

Must-have

  • Equipment Qualification in GMP environment
  • Computerized Systems Validation experience
  • Laboratory system lifecycle management
  • Root cause analysis execution
  • GxP regulatory compliance knowledge

Nice-to-have

  • LabX or Empower software experience
  • System Development Lifecycle (SDLC) expertise
  • Cross-functional team leadership skills
  • Continuous improvement mindset
  • Strategic critical thinking abilities

Key Requirements

  • Degree in scientific or technical discipline
  • Minimum 6 years of GMP work experience
  • Experience in Equipment Qualification and CSV
  • Background in QC Laboratory or Lab Systems Support

Work Rights

Not specified

Tailored Resume

Cover Letter