Posted 27 May, 2026
Computer System Validation (CSV) Specialist
Crescens Inc.
Bangalore, Karnataka, IN
Full Time
Reference: 26-00949-196-1
Job Title: Computer System Validation (CSV) Specialist
Location: Bangalore, Karnataka (onsite)
Total Experience: 7 to 9 years
Mode of Interview: Face to Face (Mandatory)
Pay Rate-Rs.750/hr
Job Description:
Mandatory Knowledge:
· End to end IT validation knowledge
· CSV approaches
· CSA approaches
· Change control knowledge
· Good communication skills
· Validation related document author and review knowledge
· Veeva & Service Now application knowledge
Skills & Experience Required:
· 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), Validation Plans, IQ/OQ/PQ protocols, Risk Assessment (System, AI-specific, and use-case-based), Traceability Matrices, Test Scripts, and Summary Reports.
Location: Bangalore, Karnataka (onsite)
Total Experience: 7 to 9 years
Mode of Interview: Face to Face (Mandatory)
Pay Rate-Rs.750/hr
Job Description:
Mandatory Knowledge:
· End to end IT validation knowledge
· CSV approaches
· CSA approaches
· Change control knowledge
· Good communication skills
· Validation related document author and review knowledge
· Veeva & Service Now application knowledge
Skills & Experience Required:
· 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), Validation Plans, IQ/OQ/PQ protocols, Risk Assessment (System, AI-specific, and use-case-based), Traceability Matrices, Test Scripts, and Summary Reports.
