Senior Manager/Lead - Computer System Validation

Job Summary :

- 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 :

- BE / B.Tech / MCA (Regular) from a recognized institute

- 10+ years of experience in IT Quality Assurance / Process Management

- Experience in QMS, SOP creation, and template authoring

- Certified Scrum Master

- Certified ISO 9001:2015 & ISO 27001 Auditor

- Strong documentation, reviewing, and requirement analysis skills

- Excellent communication and stakeholder management abilities

- Self-motivated with strong organizational skills

Good to Have (Desirable) :

- Experience in building and maintaining QMS processes

- Exposure to Agile/Scrum environments

- Experience working with MNCs