CSA and CSV practitioner with Empower or HPLC software
Infinite Computer Solutions · Washington, DC · 1 mo ago
OTHRFull-time
Location: Remote
Skills
- 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