Computer System Validation Engineer

Clinevo Technologies; Electronic City; On-site; INR 1,000,000 - 1,800,000; Full time

Job summary

Clinevo Technologies in India is seeking a QA/Validation specialist to plan, execute, and document PV system testing and validation activities. You will lead CSV and CSA efforts using a risk-based approach and prepare validation deliverables.

The role requires strong knowledge of GxP, regulatory guidelines, and client-facing communication; you will work with QA, Development, and clients to ensure traceability and timely go-live readiness.

Qualifications

• Minimum 3+ years in Pharmacovigilance system testing and validation.
• Strong hands-on experience with CSV lifecycle and documentation.
• Practical CSA application of risk-based validation principles.
• Experience creating URS, FRS, RTM, test scripts, and validation reports.
• GxP awareness, data integrity, and regulatory expectations.
• Functional, regression, and UAT coordination for PV systems.
• Excellent verbal and written client communication.

Responsibilities

• Plan, execute, and document testing and validation activities for PV systems.
• Lead CSV and CSA activities using a risk-based approach.
• Prepare, review, and maintain validation deliverables including URS, FRS, Risk Assessment, Test Scenarios, Test Scripts, RTM, and Validation Summary Reports.
• Perform functional, regression, and UAT support testing for PV applications.
• Support client implementations including requirement walkthroughs, validation strategy discussions, and go-live readiness.
• Ensure compliance with GxP, regulatory guidelines, and internal quality standards.
• Participate in change management, deviation investigations, impact assessments, and CAPA activities.
• Collaborate with Product, QA, Development, and Client stakeholders to ensure validation traceability and quality.
• Provide clear status updates and professionally handle client communications during implementation and validation phases.

Skills

PV Domain Knowledge

CSV

CSA

Regulatory Compliance

Testing

Client Communication

Tools

Jira

Azure DevOps

Change Control

Deviation

CAPA

Job description

Responsibilities:
Plan, execute, and document testing and validation activities for Pharmacovigilance (PV) systems.
Lead Computer System Validation (CSV) and Computer Software Assurance (CSA) activities using a risk-based approach.
Prepare, review, and maintain validation deliverables including URS, FRS, Risk Assessment, Test Scenarios, Test Scripts, RTM, and Validation Summary Reports.
Perform functional, regression, and UAT support testing for PV applications.
Support client implementations, including requirement walkthroughs, validation strategy discussions, and go-live readiness.
Ensure compliance with GxP, regulatory guidelines, and internal quality standards.
Participate in change management, deviation investigations, impact assessments, and CAPA activities.
Collaborate with Product, QA, Development, and Client stakeholders to ensure validation traceability and quality.
Provide clear status updates and professionally handle client communications during implementation and validation phases.

Required Skills:

PV Domain Knowledge: Minimum 3+ years of experience in Pharmacovigilance system testing and validation.
CSV: Strong hands‑on experience with Computer System Validation lifecycle and documentation.
CSA: Practical experience applying Computer Software Assurance and risk-based validation principles.
Validation Documentation: Expertise in creating URS, FRS, RTM, Test Scripts, and Validation Reports.
Regulatory Compliance: Good understanding of GxP, data integrity, and regulatory expectations.
Testing: Functional testing, regression testing, and UAT coordination for PV systems.
Client Communication: Strong verbal and written communication skills to handle client-facing implementations.
Tools & Processes: Familiarity with SDLC, Jira, Azure Devops ,change control, deviation, and CAPA processes.

Note: Interviews will be welkin for this role