CSV Consultant

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

Job summary

Infosys is seeking an IT Compliance Specialist in Bengaluru, India, with expertise in IT Quality Compliance and GxP regulations. The role involves managing validation of computerized systems and ensuring compliance with industry standards. Candidates should hold a Bachelor of Engineering and have a strong foundation in software testing and stakeholder management.

Ideal applicants will possess 5+ years of professional experience and demonstrate the ability to develop value-creating strategies that enhance business growth and profitability.

Qualifications

• 5+ years of experience in IT Quality Compliance and Software Testing.
• Strong knowledge of GxP regulations and computer systems validation.
• Ability to manage stakeholders and ensure compliance.

Responsibilities

• Manage and maintain validation of GxP computerized systems.
• Assure compliance with GxP privacy requirements.
• Develop improvement strategies and suggest technology solutions.

Skills

IT Quality Compliance

Computer System Validation

Software Testing

Stakeholder Management

Risk Management

Test Management Compliance

Education

Bachelor of Engineering

Tools

GxP Compliance Documentation

Job description

Educational Requirements

Bachelor of Engineering

Service Line

Application Development and Maintenance

Responsibilities

• 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, PQs, 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 QM, 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.

Additional Responsibilities

• 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

Technical and Professional Requirements

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

Preferred Skills

• Domain->LifeSciences->Pharma Regulations->Computer Systems Validation (CSV)