Senior Cqv Specialist

AtkinsRealis UK

Calgary, Alberta, Canada
Hybrid
Cgmp regulation requirements
Qualification and validation protocols
Risk assessments
Provides technical and project leadership with a comprehensive understanding of the pharmaceutical industry design/build/validation processes and how they relate to Canadian, EU, and US FDA cGMP regulation requirements

Job Summary

  • Provides technical and project leadership with a comprehensive understanding of the pharmaceutical industry design/build/validation processes and how they relate to Canadian, EU, and US FDA cGMP regulation requirements.
  • Develops/reviews technical documentation for clients in regulated industries including qualification and validation protocols and reports, criticality assessments, risk assessments, validation master plans, user requirements specifications, standard operating procedures and quality plans and policies.
  • Enjoy competitive compensation, employee recognition, and a brilliant range of flexible benefits you can tailor to your health, wellbeing, financial and lifestyle needs.

Matching Summary

Provides technical and project leadership with a comprehensive understanding of the pharmaceutical industry design/build/validation processes and how they relate to Canadian, EU, and US FDA cGMP regulation requirements.

Skills & Requirements

Must-have

  • cGMP regulation requirements
  • qualification and validation protocols
  • risk assessments
  • validation master plans
  • user requirements specifications
  • standard operating procedures

Nice-to-have

  • French knowledge an asset
  • pioneering vision
  • fierce pride in work

Key Requirements

  • Minimum 8 years relevant work experience
  • Bachelor’s degree in chemical or mechanical Engineering
  • Thorough knowledge of cGMP
  • Validation planning
  • IQ, OQ, PQ expertise
  • Cleaning and process Validation experience

Work Rights

Not specified

Tailored Resume

Cover Letter