CSA/CSV Validation Consultant

Role - CSA/CSV Validation Consultant

Remote

Skills & Experience Required:

empower or similar HPLC software

Deep expertise in validating GxP-regulated IT systems within the Pharma/Life Sciences domain
Familiarity with QMS processes including deviation management, CAPA, and change control.
Strong command of CSA (Computer Software Assurance) principles
Solid knowledge with 21 CFR Part 11, Annex 11, ISPE AI guidance, GxP data integrity principles (ALCOA+).
Proven ability to write and manage validation deliverables including Test Strategy (Risk-based testing, CSA),\ HPLC software