Lead Computer System Validation

Actively Reviewing the Applications

YO IT Consulting

4–8 years

Posted 2 days ago • Apply by June 11, 2026

Job Description

Experience: 10-15 Years

Location: Noida

Job Summary

We are looking for an experienced Sr Manager / Lead - CSV QA to drive Quality Assurance and Computer System Validation (CSV) initiatives. The candidate will be responsible for maintaining and enhancing the Quality Management System (QMS), ensuring compliance with ISO standards, and supporting internal and external audits.

This role requires strong expertise in process management, documentation, stakeholder coordination, and quality compliance within the IT/software industry. The ideal candidate should be a certified ISO auditor and Scrum Master with a deep understanding of software development methodologies and quality practices.

Must-Have Skills

Quality Assurance (QA)
Computer System Validation (CSV)
Stakeholder Management
MS Office (Advanced proficiency)
Quality Management System (QMS)
Internal & ISO Audits
Qualification Scripts (IQ, OQ, PQ)
Agile / Scrum (Certified Scrum Master)
ISO 9001:2015 & ISO 27001 Auditing

Key Responsibilities

Maintain and enhance the Quality Management System (QMS)
Define and implement processes to ensure high-quality deliverables
Conduct and manage internal audits and support external audits
Drive continuous improvement and defect reduction initiatives
Review CSV deliverables: URS, Validation Plan, Test Plan, Traceability Matrix, Test Summary & Validation Reports
Review qualification documents (IQ, OQ, PQ scripts, results, reports)
Track and close non-conformances from audits
Coordinate with stakeholders and function heads for process improvements
Support training programs related to processes and quality standards
Ensure compliance with ISO 9001:2015 and ISO 27001 standards

Must-Have Qualifications