CSV Lead: GxP Systems Validation (Remote)

Capgemini; Hyderabad City Taluka; Hybrid; PKR 20,747,000 - 29,046,000; Full time

Benefits offered by this job

Flexible work hours

Remote work option

Job summary

Capgemini Invent in Hyderabad is seeking a skilled Computer Systems Validation (CSV) lead to guide GxP-regulated systems through the SDLC. You will collaborate with Quality, IT and external vendors to ensure validated, compliant implementations that meet FDA 21 CFR Part 11 requirements and QMS standards.

You will prepare and review validation plans, protocols and reports, oversee testing, risk assessments, change controls and traceability matrices, and drive continuous improvement.

Qualifications

• Experience leading CSV activities across the system lifecycle.
• Knowledge of GxP, FDA 21 CFR Part 11 and QMS requirements.
• Ability to prepare and review validation plans, protocols and reports.

Responsibilities

• Lead and support CSV activities for GxP-regulated systems through SDLC.
• Review validation deliverables, risk assessments, testing docs, and change controls.
• Collaborate with QA, IT, business and vendors to ensure compliant implementations.
• Maintain traceability, audit-ready records and data migration validation.

Skills

CSV leadership

Regulatory compliance

GxP standards

Risk assessment

Job description

Capgemini Invent in Hyderabad is seeking a skilled Computer Systems Validation (CSV) lead to guide GxP-regulated systems through the SDLC. You will collaborate with Quality, IT and external vendors to ensure validated, compliant implementations that meet FDA 21 CFR Part 11 requirements and QMS standards.

You will prepare and review validation plans, protocols and reports, oversee testing, risk assessments, change controls and traceability matrices, and drive continuous improvement.