Csv Consultant Para Feira De Santana

Tata Consultancy Services Ver todas as vagas

  • Feira de Santana - BA
  • Permanente
  • Período integral
  • Há 1 dia
Cargo:Csv Consultant – Feira de Santana – Tata Consultancy Services
Requisito:CSV Consultant (Computerized System Validation) – Tata Consultancy Services – Feira de Santana, Estado da Bahia, Brazil.TCS is one of the largest IT services companies worldwide, offering a culture of unlimited learning and continuous improvement in a collaborative environment.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.
  • Provide recommendations to close existing compliance gaps and improve processes.
  • Ensure compliance with SOPs, policies, and procedures.
  • Conduct and coordinate periodic reviews of GxP applications.
  • Conduct Access Roster reviews, Audit Trail review processes, and finalize review reports.
Requirements
  • CSV expertise.
  • Experience in R&D/Clinical, Quality/Mfg, ERP/SAP GxP modules.
  • Knowledge of 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 using Document management tools such as Valgenesis, Veeva Vault, etc.
  • Fluent English.
Benefits – Brazil
  • Health insurance
  • Dental Plan
  • Life insurance
  • Transportation vouchers
  • Meal/Food Voucher
  • Childcare assistance
  • Totalpass
  • TCS Cares – free 0800 providing psychological, legal, social, and financial assistance 24/7
  • 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 – referral 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 and 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 other characteristic.#J-18808-Ljbffr
Salário:A combinar
Benefícios:Não foi informado

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