CSV Team member

Bahwan CyberTek; Chennai District, Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Bahwan CyberTek seeks an experienced CSV specialist to ensure GMP/GxP compliance within a regulated pharma/life sciences environment. You will drive validation activities and maintain audit readiness across validated systems.

You will prepare, review, and approve validation deliverables such as Validation Plans, Risk Assessments, URS, FS, IQ/OQ/PQ, SIT, UAT, and Validation Summary Reports while supporting SAP validations throughout the project lifecycle.

Qualifications

• 8+ years of experience in Computer System Validation (CSV) within the pharmaceutical or life sciences industry.
• Strong knowledge of GxP regulations, FDA requirements, and industry compliance standards governing validated systems.
• Proven experience in preparing, reviewing, and approving validation deliverables, including Validation Plans, Risk Assessments, URS, FS, Traceability Matrix, Test Scripts, IQ/OQ/PQ, SIT, UAT, and Validation Summary Reports.
• Expertise in ensuring regulatory compliance, audit readiness, data integrity, and system validation throughout the project lifecycle.
• Capable of supporting validation strategy, testing execution, compliance reviews, defect management, document signoffs, go-live readiness, and hyper care support for SAP implementations in a regulated environment.

Responsibilities

• Support validation strategy, testing execution, and compliance reviews.
• Manage defect resolution, document signoffs, and go-live readiness.
• Provide hyper care support for SAP implementations in regulated environments.

Skills

CSV

GxP compliance

FDA requirements

Validation deliverables

Tools

SAP

Job description

Location - Ahmedabad & Work hours - in office 5 days a week and two saturdays a month

8+ years of experience in Computer System Validation (CSV) within the pharmaceutical or life sciences industry.
Strong knowledge of GxP regulations, FDA requirements, and industry compliance standards governing validated systems.
Proven experience in preparing, reviewing, and approving validation deliverables, including Validation Plans, Risk Assessments, URS, FS, Traceability Matrix, Test Scripts, IQ/OQ/PQ, SIT, UAT, and Validation Summary Reports.
Expertise in ensuring regulatory compliance, audit readiness, data integrity, and system validation throughout the project lifecycle.
Capable of supporting validation strategy, testing execution, compliance reviews, defect management, document signoffs, go-live readiness, and hyper care support for SAP implementations in a regulated environment.

Required Skills

8+ years of experience in Computer System Validation (CSV) within the pharmaceutical or life sciences industry.
Strong knowledge of GxP regulations, FDA requirements, and industry compliance standards governing validated systems.
Proven experience in preparing, reviewing, and approving validation deliverables, including Validation Plans, Risk Assessments, URS, FS, Traceability Matrix, Test Scripts, IQ/OQ/PQ, SIT, UAT, and Validation Summary Reports.
Expertise in ensuring regulatory compliance, audit readiness, data integrity, and system validation throughout the project lifecycle.
Capable of supporting validation strategy, testing execution, compliance reviews, defect management, document signoffs, go-live readiness, and hyper care support for SAP implementations in a regulated environment.