CSV R&D Consultant

Tata Consultancy Services; Brasil; On-site; BRL 180,000 - 240,000; Full time

Benefits offered by this job

Psychological assistance

Learning portal

Certifications reimbursement

International experience

Referral bonus

Mentoring platform

Job summary

Tata Consultancy Services in Brazil is seeking a CSV R&D Engineer to join our highly regulated validation team. You will design and execute validation activities for GxP systems, author URS/FS, and support audits with risk-based testing.

The ideal candidate has 8+ years of overall experience with at least 5 years in computer system validation, a strong grasp of CFR Part 11/820, GxP, and ITIL, and can work in a fast-paced IT services environment.

Qualifications

• Bachelor-level degree in science/tech or pharmacy.
• 8+ years total experience with at least 5 years in Computer System validation for GxP systems.
• Strong knowledge of 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, and ITIL.
• Experience with Deviation/CAPA management and SOP/policy compliance processes.
• High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, and Regulatory Affairs.

Responsibilities

• Author URS/FS, protocols, validation plans/reports, and final reports.
• Perform risk-based testing aligned to CSA fundamentals.
• Assess and document data integrity controls, including ALCOA+ principles.
• Manage validation risk assessment (impact/criticality) and translate it into test coverage and RTM.
• Support audits and inspections by presenting evidence and handling observations.

Skills

GxP knowledge

Validation testing

Data integrity

Audit readiness

URS/FS docs

Education

Bachelor of Science

Bachelor of Technology

Bachelor’s in Pharmacy

Tools

JIRA

ALM

Azure DevOps

HP QC

Vault QualityDocs

Veeva Vault

Job description

Come to one of the biggest IT Services companies in the world! Here you can transform your career!

We are looking for a CSV R&D Engineer who wants to learn and transform his/her career.

Requirements

• Bachelor of Science, Bachelor of Technology, or Bachelor’s in Pharmacy.
• Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP systems.
• Strong knowledge of 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, and ITIL.
• Experience with Deviation/CAPA management and SOP/policy compliance processes.
• High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, and Regulatory Affairs.
• Experience with RPA GxP BOTs and R&D AI GxP.
• Experience in audit/inspection readiness, periodic reviews, access roster, and audit trail reviews.

Nice to Have

• High-level understanding of Veeva Vault suits.
• Experience using tools such as JIRA, ALM, Azure DevOps, HP QC, or Vault QualityDocs.
• Experience validating cloud/SaaS systems used in R&D.

Key Responsibilities

• Author URS/FS, protocols, validation plans/reports, and final reports.
• Perform risk-based testing aligned to CSA fundamentals.
• Assess and document data integrity controls, including ALCOA+ principles.
• Manage validation risk assessment (impact/criticality) and translate it into test coverage and RTM.
• Support audits and inspections by presenting evidence and handling observations.

What do we offer?

• TCS Cares – free 0800 that provides psychological assistance (24 hrs/day), legal, social and financial assistance to associates
• Partnership with SESC
• Reimbursement of Certifications
• Free TCS Learning Portal – Online courses and live training
• International experience opportunity
• Discount Partnership with Universities and Language Schools
• Bring Your Buddy – By referring people you become eligible to receive a bonus for each hire
• Xcelerate – Free Mentoring Career Platform

Employment Type

CLT

Compensation

Salary to be discussed + benefits

Tata Consultancy Services is an equal opportunity employer. Our commitment to diversity and inclusion drives our efforts to provide equal opportunities to all candidates who meet our required knowledge and competency needs, regardless of socio-economic background, race, color, national origin, religion, sex, gender identity or expression, age, marital status, disability, sexual orientation or any other characteristic.

At Tata Consultancy Services, we promote an inclusive culture and continuously work for equity. This applies to Gender, People with Disabilities, LGBTQIA+, Religion, Race, and Ethnicity. All our opportunities are based on these principles, reinforcing our commitment to building a workplace that respects and values every individual.