Senior Cqv Engineer

Thermo Fisher Scientific UK

Switzerland
Gmp systems requalification strategy
External contractor coordination
Good documentation practices
Prepares, reviews and approves production, validation, audit reports documents, procedures, and rationales

Job Summary

  • Prepares, reviews and approves production, validation, audit reports documents, procedures, and rationales.
  • Evaluates new regulations, changes to existing regulations and regulatory trends; prepares inspections and customer audit responses and reports.
  • Defines, in collaboration with other partners (Quality Assurance, System Owner…) the requalification strategy of GMP systems and implements it.

Matching Summary

Prepares, reviews and approves production, validation, audit reports documents, procedures, and rationales.

Skills & Requirements

Must-have

  • GMP systems requalification strategy
  • external contractor coordination
  • Good Documentation Practices
  • continuous improvement culture
  • cGMPs and manufacturing operations
  • pharmaceutical industry experience

Nice-to-have

  • collaboration and innovation
  • dedication to excellence
  • German or another European language

Key Requirements

  • Bachelor’s degree + 10 years experience
  • Master's degree + 3 years experience
  • Experience in FDA regulated facility
  • Experience in pharmaceutical industry for qualification & validation

Work Rights

Not specified

Tailored Resume

Cover Letter