Computer System Validation Engineer

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