MUST HAVE
Data integrity background This person will have come from a pharma background See more info below Potential Job titles:
- CSV Analyst
- Validation Specialist
- QA Systems Analyst
- Compliance Specialist
- GMP Systems Analyst
- Quality Systems Specialist
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IT Compliance Analyst Required Experience:
Working knowledge of Computer System Validation (CSV), Data Integrity principles, and regulatory requirements for computerized systems, including 21 CFR Part 11 and EU Annex 11. Experience with Quality Systems such as Veeva for document authoring and Quality Management (Change Controls, Deviations, CAPAs). Relevant experience working with laboratory/manufacturing equipment such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV would be a plus. Relevant experience with instruments such as Spectramax, Zetasizer, MACSQuant, SoloVPE, Hamilton, BacT with MYLA software, or other similar laboratory instruments would be a plus.