Lifesciences Domain Consultant

Virtusa; Chennai District; Sur place; INR 1 800 000 - 3 000 000; Plein temps

Résumé du poste

Virtusa is seeking a seasoned Life Sciences IT specialist to provide domain expertise across critical testing and transformation initiatives in GxP, CSV, and regulatory compliance.

You will analyze processes, identify standardization opportunities, create reusable assets, and guide validation strategy and documentation.

Candidates with 10–12 years in Life Sciences/Pharma IT, QA or Consulting, with strong GxP and data integrity knowledge, are encouraged to apply.

Qualifications

• 10–12 years of experience in Life Sciences/Pharma IT, Testing, Validation, QA or Consulting.
• Strong expertise in GxP, CSV, 21 CFR Part 11, GAMP 5, ALCOA+ and Data Integrity.
• Experience with GxP validation documentation and risk-based testing.
• Pharma/Life Sciences client experience is preferred.

Responsabilités

• Provide Life Sciences, GxP and CSV expertise across critical R&D, Clinical, Safety, Regulatory and other GxP projects.
• Analyze business processes and testing workflows to identify opportunities for standardization, reuse, automation and efficiency improvements.
• Identify common testing activities and opportunities to create reusable domain assets, templates and accelerators across projects.
• Support teams in understanding business-critical workflows, system interfaces, data flows and end-to-end processes.
• Ensure transformation initiatives align with GxP, 21 CFR Part 11, GAMP 5, ALCOA+ and Data Integrity principles.
• Provide guidance on validation strategy, risk assessment, requirements, test strategy, traceability and validation documentation.
• Review URS, functional specs, risk assessments, validation plans/reports, traceability matrices, test protocols/scripts, deviations, defects and release documentation.
• Assess AI, automation and agentic testing opportunities from a business, GxP, validation and human-in-the-loop perspective.

Connaissances

Life Sciences

GxP

CSV

21 CFR Part 11

GAMP 5

ALCOA+

Data Integrity

Validation

Testing

AI adoption

Description du poste

Job Requirements

Role Overview: Provide Life Sciences, GxP and pharmaceutical domain expertise across critical AZ testing and transformation initiatives while identifying opportunities to improve productivity, standardize processes and create value across projects. The role will act as a shared domain SME, supporting testing teams and transformation initiatives while driving measurable efficiency and quality improvements. Key Responsibilities: Provide Life Sciences, GxP and Computer System Validation (CSV) expertise across critical R&D, Clinical, Safety, Regulatory and other GxP projects. Analyse business processes and testing workflows across projects to identify opportunities for standardization, reuse, automation, AI adoption and efficiency improvement. Identify common testing activities, duplicated effort and opportunities to create reusable domain assets, templates and accelerators across projects. Support teams in understanding business-critical workflows, system interfaces, data flows and end-to-end processes. Ensure transformation initiatives align with GxP, 21 CFR Part 11, GAMP 5, ALCOA+ and Data Integrity principles. Provide guidance on validation strategy, risk assessment, requirements, test strategy, traceability and validation documentation. Review and provide SME guidance on URS, functional specifications, risk assessments, validation plans/reports, traceability matrices, test protocols/scripts, deviations, defects and release documentation. Assess AI, automation and agentic testing opportunities from a business, GxP, validation and human-in-the-loop perspective. Partner with the Agentic Transformation Lead, Data Architect and project teams to identify and implement AI-enabled and domain-led value adds. Track and demonstrate efficiency improvements, reuse opportunities, quality benefits and value delivered across projects. Required Skills & Experience: 10–12 years of experience in Life Sciences/Pharma IT, Testing, Validation, QA or Consulting. Strong expertise in GxP, CSV, 21 CFR Part 11, GAMP 5, ALCOA+ and Data Integrity. Strong understanding of Clinical, R&D, Pharmacovigilance, Regulatory and/or Manufacturing processes. Experience with GxP validation documentation and risk-based testing. Ability to work across multiple projects and convert domain knowledge into practical efficiency and value‑add opportunities. Pharma/Life Sciences client experience is preferred.