Csv Senior Compliance Advisor - Labs & Test Equipment

ConvaTec Group

Deeside, Wales, United Kingdom
Hybrid
Gxp regulatory compliance knowledge
Laboratory system validation experience
Data integrity alcoa+ principles
The role ensures laboratory systems and test equipment supporting GxP activities are validated and maintained in a compliant state

Job Summary

  • The role ensures laboratory systems and test equipment supporting GxP activities are validated and maintained in a compliant state.
  • Candidates must possess strong organizational skills to manage multiple priorities in a regulated medical device environment.
  • This position operates on a flexible hybrid working model with required on-site presence at the Deeside, Wales location.

Matching Summary

The role ensures laboratory systems and test equipment supporting GxP activities are validated and maintained in a compliant state.

Skills & Requirements

Must-have

  • GxP regulatory compliance knowledge
  • Laboratory system validation experience
  • Data integrity ALCOA+ principles
  • IQ OQ PQ equipment qualification
  • Risk assessment for computerized systems

Nice-to-have

  • SaaS LIMS application experience
  • Enterprise IT application validation
  • Legacy data migration skills
  • Continuous improvement mindset
  • Cross-functional collaboration skills

Key Requirements

  • Bachelor's degree in Life Sciences or Engineering
  • 5+ years of CSV experience
  • Experience in medical device industry
  • Hands-on experience with GCMS and ICPMS
  • Knowledge of 21 CFR Part 11 and EU Annex 11

Work Rights

Not specified

Tailored Resume

Cover Letter