Computer System Validation Consultant - Life Sciences

Infosys; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Infosys is seeking a seasoned CSV Consultant in Life Sciences to lead validation of GxP computerized systems, develop validation plans and generate comprehensive validation reports. You will ensure regulatory alignment with GxP, privacy rules, and industry guidelines across projects.

The role requires 5+ years of IT Quality & Compliance experience in Life Sciences, strong stakeholder management, and the ability to handle URS/FS/IQ-OQ-PQ artifacts in a fast-paced environment.

Qualifications

• 5+ years of IT Quality & Compliance experience in Life Sciences with real-time validation/testing exposure.
• Experience in Computer System Validation / Software Testing / System Implementation for Life Sciences.
• Familiar with GxP compliance, privacy requirements and related documentation (URS, FS, IQ/OQ/PQ).
• Understanding of 21 CFR Part 11, EU Annex 11, and GAMP5 guidelines.
• Knowledge of IT QMS, Validation/Qualification, Risk management, CAPA, and defect handling.

Responsibilities

• Lead validation of GxP computerized systems and create validation documents.
• Develop Validation Plans and Reports; review URS, FS, IQ/OQ/PQ.
• Ensure GxP compliance and IT GxP documentation.
• Coordinate with stakeholders and manage cross-functional teams.
• Handle investigations, CAPA, and risk management.

Skills

Logical thinking

Problem solving

Collaboration

Client interfacing

Project management

Team management

Tools

Software configuration management systems

Job description

CSV Consultant Primary skills:Domain->LifeSciences->LifeSciences - ALL

Ability to develop value-creating strategies and models that enable clients to innovate, drive growth and increase their business profitability

• Good knowledge on software configuration management systems
• Awareness of latest technologies and Industry trends
• Logical thinking and problem solving skills along with an ability to collaborate
• Understanding of the financial processes for various types of projects and the various pricing models available
• Ability to assess the current processes, identify improvement areas and suggest the technology solutions
• One or two industry domain knowledge
• Client Interfacing skills
• Project and Team management

Key components of the responsibilities are as mentioned below but not limited to:

• 5+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.
• Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.
• Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.
• Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.
• Stakeholder management and good executor with required communication.
• Candidate must have fair conceptual understanding on below key areas
  • IT QMS
  • Validation/Qualification
  • Risk management.
  • Handling of defects/Deviations
  • Investigations
  • CAPA Handling
  • Test Management & Compliance
• Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.
• Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc.