Senior Computer System Validation (CSV) Consultant – GxP Systems

Tata Consultancy Services; São Paulo; Presencial; BRL 180 000 - 240 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

International experience

Career development platform

Learning platform with free training

24/7 Employee Assistance Program

Resumo da oferta

Tata Consultancy Services seeks a Senior Computer System Validation (CSV) Consultant to fortify compliance, quality, and innovation in global Life Sciences and R&D environments.

Bring 8+ years of experience, with 5+ in CSV for GxP-regulated systems, and expertise in regulatory standards and validation lifecycles. You will contribute to audits and risk-based testing within AI-enabled and digital transformation projects.

Qualificações

• Bachelor’s degree in science/tech/pharma or related field.
• 8+ years of overall experience with at least 5 years in CSV for GxP-regulated systems.
• Strong knowledge of GxP, regulatory standards, and validation lifecycle.

Responsabilidades

• Lead CSV validation activities across GxP systems.
• Prepare and review URS, FS, Validation Plans/Protocols/Reports.
• Support audit readiness and inspection activities.
• Apply risk-based testing aligned with CSA principles.

Conhecimentos

GxP regs

21 CFR Part 11

21 CFR Part 820

GAMP 5

SOX compliance

ISO 9001

ITIL

Audit readiness

Validation docs

CSA principles

Formação académica

Bachelor's Degree in Science, Technology, Pharmacy, or a related field

Ferramentas

Veeva Vault Suite

Descrição da oferta de emprego

Join our team as a Senior Computer System Validation (CSV) Consultant and play a key role in ensuring compliance, quality, and innovation across global Life Sciences and R&D environments.

We are seeking an experienced professional with a strong background in GxP-regulated systems, validation methodologies, and risk-based compliance practices. This is an excellent opportunity to work on cutting-edge projects involving digital transformation, AI-enabled solutions, and global R&D platforms.

Qualifications

• Bachelor's Degree in Science, Technology, Pharmacy, or a related field.
• 8+ years of overall professional experience.
• Minimum of 5 years of hands-on experience in Computer System Validation (CSV) for GxP-regulated systems.

Key Skills & Experience

Core CSV Expertise

• Strong knowledge of:
• 21 CFR Part 11 and 21 CFR Part 820
• GxP regulations
• GAMP 5
• SOX compliance
• EU Annex 11 and Annex 22
• ISO 9001
• ITIL framework
• Experience with:
• Audit and inspection readiness activities
• Periodic system reviews
• Access roster reviews
• Audit trail reviews
• Deviation and CAPA management
• SOP and policy compliance processes
• Proven experience authoring and reviewing:
• User Requirements Specifications (URS)
• Functional Specifications (FS)
• Validation Plans
• Validation Protocols
• Validation ReportsFinal Summary Reports
• High-level understanding of Veeva Vault Suite applications.
• Experience with risk-based testing methodologies aligned with CSA (Computer Software Assurance) principles.

Research & Development (R&D)

• Clinical Research
• Drug Discovery
• Medical Affairs
• Regulatory Affairs
• RPA GxP Bots
• AI-enabled GxP solutions in R&D environments

What You Can Expect From Us

• Continuous professional development aligned with your career goals.
• Opportunities for international experience.
• A collaborative, diverse, and innovative work environment.
• Exposure to global projects and cutting-edge technologies.
• Strong focus on career growth, learning, and professional advancement.
• 24/7 Employee Assistance Program (psychological, legal, and financial support)
• Learning Platform with free training and courses
• Mentorship and Career Development Platform