Computerized System Validation

Tata Consultancy Services; Brasil; On-site; BRL 60,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Gympass

TCS Cares

Reimbursement for certifications

Free TCS Learning Portal

International experience opportunity

Discount partnership with universities

Bring Your Buddy

TCS Gems

Xcelerate

Job summary

A global consulting firm located in Brazil is looking for a CSV Consultant to enhance regulatory and quality compliance across IT systems. The ideal candidate will have strong expertise in Computerized System Validation, FDA regulations, and familiarity with document management tools like Valgenesis and Veeva Vault. The role includes working alongside IT stakeholders, reviewing deliverables, and ensuring compliance with established policies. Comprehensive benefits such as health insurance, life insurance, and free training opportunities are offered.

Qualifications

• Experience in Computerized System Validation (CSV) to support regulatory compliance.
• Familiarity with FDA regulations and GxP regulations.
• Strong understanding of ITIL processes and compliance standards.

Responsibilities

• Collaborate with IT stakeholders on regulatory risk assessments.
• Review validation deliverables and provide project support.
• Ensure compliance with SOPs and policies.
• Conduct reviews of GxP applications.

Skills

CSV

FDA regulations 21 CFR Part 11

Experience with document management tools

ISO 9001

GxP

Tools

Valgenesis

Veeva Vault

Job description

CSV Consultant (Computerized System Validation)

Seeking a consultant with experience in Computerized System Validation (CSV) to support regulatory and quality compliance across IT systems.

Mandatory Skills

• CSV
• FDA regulations 21 CFR Part 11, 21 CFR Part 820, GxP Regulations, GAMP 5, SOX Regulations, EU Annex 11, EU Annex 22, ISO 9001, ITIL processes
• Experience with document management tools such as Valgenesis, Veeva Vault

Key Responsibilities

• Collaborate with IT stakeholders to conduct regulatory risk assessments of quality systems, solutions, and services.
• Review validation deliverables, including Requirements Specifications (URS/FS), Test Protocols, and Final Reports.
• Provide quality support for projects and application and infrastructure changes.
• Support audit and inspection readiness of regulated solutions.
• Guide IT stakeholders on documents and records management.
• Recommend actions to close compliance gaps and improve processes.
• Ensure compliance with SOPs, policies, and procedures.
• Conduct and coordinate periodic reviews of GxP applications.
• Perform access roster reviews, audit trail reviews, and finalize review reports.

Key Words

• CSV Computerized System Validation
• GxP
• Regulatory System
• Pharmaceutical Area

What do we offer?

• Health insurance
• Life insurance
• Gympass
• TCS Cares – free 0800 providing psychological, legal, social and financial assistance to associates
• Partnership with SESC
• Reimbursement for certifications
• Free TCS Learning Portal – online courses and live training
• International experience opportunity
• Discount partnership with universities and language schools
• Bring Your Buddy – referral bonus program
• TCS Gems – recognition for performance
• Xcelerate – free mentoring career platform

Tata Consultancy Services is an equal opportunity employer. We are committed to diversity & inclusion and provide equal opportunity to all candidates who meet our required knowledge & competency needs, irrespective of socio-economic background, race, color, national origin, religion, sex, gender identity/expression, age, marital status, disability, sexual orientation or any other characteristic. We encourage anyone interested to build a career in TCS to participate in our recruitment & selection process.

At Tata Consultancy Services we promote an inclusive culture, always work for equity across gender, people with disabilities, LGBTQIA+, religion, race, ethnicity. Our opportunities are based on these principles.