Keywords for Sourcing: CSV, Computer System Validation, CSA, Computer Software Assurance, GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+, GMP, GLP, GCP, IQ, OQ, PQ, URS, FS, Validation Plan, Traceability Matrix, Validation Summary Report, CAPA, Change Control, Data Integrity, Pharmaceutical, Biotech, Medical Device, Quality Systems, SDLC, Compliance. Preferred qualifications include 7-10 years of CSV experience, at least 1 year working under FDA CSA guidance, experience supporting audits, CAPAs, and change controls, ASQ Certifications (CSQE, CQA, CQE), PMP or Agile certification, and experience with laboratory, quality, manufacturing, clinical, or enterprise systems.