IND-Validation Consultant

NexInfo Solutions, Inc.; Chennai; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

NexInfo Solutions, Inc. seeks a Senior CSV/CSA professional to support customer deployment and validation engagements for regulated Life Sciences clients in India.

You will plan and execute risk-based CSVs and CSA activities, coordinating with Quality, Validation, IT and implementation teams to deliver compliant, review-ready deliverables and go-live readiness. Responsibilities include creating validation plans, tracking evidence, risk assessments, IQ/OQ/PQ, UAT, traceability, deviations, and

Qualifications

• Bachelor’s degree in Engineering, Computer Science, IT, Pharmacy, Life Sciences or related discipline.
• Hands-on CSV/CSA experience in regulated Life Sciences environments; validation documentation and protocol execution; risk-based testing, traceability, deviation management and UAT; GxP and regulatory knowledge; enterprise application deployment experience.

Responsibilities

• Prepare and execute validation plans, risk assessments, URS/functional specifications, requirements traceability, IQ/OQ/PQ where applicable, UAT and validation summary reports.
• Maintain test evidence and manage deviations.
• Validate configured workflows, access roles, approvals and electronic records; coordinate testing, defect triage, retesting, change-impact assessment, go-live readiness and handover.
• Apply GxP, GAMP 5, 21 CFR Part 11, EU Annex 11 and data-integrity principles as relevant. Follow customer-approved SOPs, maintain audit-ready records and coordinate Quality reviews.
• Track validation deliverables, risks, dependencies and milestones; collaborate with project managers and technical teams; escal… etc

Skills

CSV/CSA experience

Regulated life sciences

Regulatory knowledge

Customer communication

Education

Bachelors in Engineering/CS/IT/Pharmacy/Life Sciences

Job description

NexInfo is a premier consulting firm founded in 1999. We have been in business for 26+ years and work with clients of all sizes to achieve ‘Operational Excellence’ using a blend of knowledge in both Business Processes and Software Consulting. We offer implementation and managed services for businesses across many industries including Manufacturing, Pharmaceuticals, Biotech, Medical Devices, Industrial Automation, Automobile Industry, and many more. We have a global footprint across North America, Europe, and Asia with most clients distributed across North America with a team size of 300+ employees and our headquarters in California, USA.

Role Overview

Support the customer deployment and implementation engagements by planning and executing risk-based computerized system validation (CSV) and computer software assurance (CSA) activities. Work with customer Quality, Validation, IT and implementation stakeholders to produce compliant, review-ready deliverables and support go-live readiness.

Key Responsibilities

• Prepare and execute validation plans, risk assessments, URS / functional specifications, requirements traceability, IQ/OQ/PQ where applicable, UAT and validation summary reports.
• Maintain test evidence and manage deviations.
• Validate configured workflows, access roles, approvals and electronic records; coordinate testing, defect triage, retesting, change-impact assessment, go-live readiness and handover.
• Apply GxP, GAMP 5, 21 CFR Part 11, EU Annex 11 and data-integrity principles as relevant. Follow customer-approved SOPs, maintain audit-ready records and coordinate Quality reviews.
• Track validation deliverables, risks, dependencies and milestones; collaborate with project managers and technical teams; escal… etc

Required Skills

• Bachelor’s degree in Engineering, Computer Science, IT, Pharmacy, Life Sciences or a related discipline.
• Hands-on CSV/CSA experience in regulated Life Sciences environments; validation documentation and protocol execution; risk-based testing, traceability, deviation management and UAT; GxP and regulatory knowledge; enterprise application deployment experience; clear customer communication.

Seniority Level: Senior

Employment Type: Full-Time

Shift Timing: CST (5:00 PM – 2:30 AM IST)