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