Hiring "Training & SoP Author Lead - Regulatory" | 100% Remote (UK/EU)

Posted 2 days 12 hours ago by Smartedge Solutions Ltd

Contract
Not Specified
Training Jobs
London, United Kingdom
Job Description

Experience:

  • Bachelor's or Master's degree in Pharmaceutical, Computer Science, IT, Engineering, or a related field.
  • 10+ years of experience in Computer System Validation (CSV) in the pharmaceutical, biotech, or medical device industry.
  • Strong knowledge of GxP, 21 CFR Part 11, GAMP 5, Data Integrity, and Annex 11.
  • Experience in validating SaaS applications used in the pharmaceutical industry.
  • Familiarity with Veeva Vault RIMS, QualityDocs, or Submissions Archive is a plus.
  • Excellent documentation skills and experience with validation life cycle documentation.
  • Ability to work independently and collaborate with cross-functional teams.