Wanted: Csv Consultant

Tata Consultancy Services; Macapá; Presencial; BRL 78 000 - 145 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Dental Plan

Life insurance

Transportation vouchers

Meal/Food Voucher

Childcare assistance

Totalpass

TCS Cares – assistência 24h

Resumo da oferta

A Tata Consultancy Services está buscando um(a) CSV Consultant para validar sistemas computacionais em um ambiente regulado no Brasil. O papel envolve colaboração com TI, revisão de entregáveis de validação e suporte à qualidade em mudanças de aplicações e infraestrutura.

É exigido conhecimento em GxP, regulamentações relevantes (FDA, EU, ISO) e inglês fluente. A vaga oferece benefícios TCS no Brasil e oportunidades de desenvolvimento profissional.

Qualificações

• CSV
• R&D/Clinical ou Quality/Mfg ou ERP/SAP GxP Modules
• FDA regulations 21 CFR Part 11, 820, EU Annex 11, SOX, ISO 9001, ITIL
• Experiência com ferramentas de gestão de documentos (Valgenesis, Veeva Vault)
• Inglês fluente

Responsabilidades

• Colaborar com partes interessadas de TI para avaliação de risco regulatório
• Revisar entregáveis de validação: URS/FS, Protocolos de Teste e Relatórios Finais
• Oferecer suporte de qualidade para projetos e mudanças de aplicação e infraestrutura
• Apoiar preparação para auditorias e inspeções de soluções regulamentadas
• Orientar TI em gestão de documentos e registros
• Propor melhorias para fechar lacunas de conformidade
• Garantir conformidade com SOPs, políticas e procedimentos
• Conduzir revisões periódicas de aplicações GxP
• Conduzir revisão de Access Roster, Audit Trail e relatórios finais

Conhecimentos

CSV

Conformidade regulatória

GxP e regulamentações

Documentação

Inglês fluente

Ferramentas

Valgenesis

Veeva Vault

Descrição da oferta de emprego

Wanted: CSV Consultant Tata Consultancy Services•macapá, estado do amapá, br

Descrição da vaga

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

Why to join TCS? Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools, contributing to our success in a collaborative environment.

We are looking for a CSV Consultant (Computerized System Validation).

In this role you will:

• Collaborate with IT stakeholders for conducting Regulatory Risk Assessment of quality systems, solutions and services
• Review of validation deliverables, including Requirements Specifications (URS/FS), Test Protocols, and Final Reports.
• Provide Quality support for the Projects and Application and Infrastructure changes
• Support of Audit and Inspection Readiness of regulated solutions
• Guiding IT stakeholder on Documents and Records Management
• Providing recommendations to close the existing compliance gaps and improve the processes
• Ensuring compliance to SOPs, policies and procedures
• Conducting and coordinating periodic review of GxP applications
• Conducting Access Roster review, Audit Trial review processes and finalizing review reports

We have some requirements:

• CSV
• R&D/Clinical ou Quality/Mfg ou ERP/SAP GxP Modules
• FDA regulations 21 CFR Part 11 (Electronic Records and Electronic Signatures, Audit Trails and Security events), 21 CFR Part 820, GxP Regulations, GAMP 5, SOX Regulations, EU Annex 11, EU Anness 22, ISO 9001, ITIL processes
• Experience of using Document management tools such as Valgenesis, Veeva Vault etc.
• Fluent English

What do we offer?

TCS Benefits – Brazil:

• Health insurance
• Dental Plan
• Life insurance
• Transportation vouchers
• Meal/Food Voucher
• Childcare assistance
• Totalpass
• 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
• TCS Gems – Recognition for performance
• Xcelerate – Free Mentoring Career Platform
• Tata Consultancy Services is an equal opportunity employer, our commitment to diversity & inclusion drives our efforts to provide equal opportunity to all candidates who meet our required knowledge & competency needs, irrespective of any socio-economic background, race, color, national origin, religion, sex, gender identity/expression , age, marital status, disability, sexual orientation or any others. 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, we always work for equity. This applies to Gender, People with Disabilities, LGBTQIA+, Religion, Race, Ethnicity. All our opportunities are based on these principles. We think of different actions of inclusion and social responsibility, in order to build a TCS that respects individuality. Come to be a TCSer!

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Wanted: CSV Consultant • macapá, estado do amapá, br