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Amaris Consulting

CSV Specialist

Amaris Consulting

Posted

3 weeks ago

Singapore, Singapore

Onsite

SGD 8K

Mid Level

Full Time

Match

Skills

Experience

Industry

Sema

Sema Summary

The CSV Specialist will lead validation projects for computerized systems in compliance with regulatory standards. This role requires extensive experience in Computer Systems Validation and collaboration with cross-functional teams.

About Company

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses globally. With a diverse team and a focus on innovation, they support clients in various sectors including IT, telecom, and life sciences.

Core Requirements

  • Bachelor's degree in engineering or life sciences
  • 8-10 years of experience in CSV or related roles
  • Strong knowledge of GxP and FDA regulations
  • Ability to manage multiple projects
  • Excellent analytical and problem-solving skills

Responsibilities

  • Lead validation projects for computerized systems
  • Develop and maintain CSV standards and procedures
  • Author and review validation documentation
  • Ensure compliance with regulatory requirements
  • Collaborate with IT, Quality, and Engineering teams
  • Drive continuous improvement of validation processes
  • Support internal and external audits

Benifits

  • Global Diversity
  • Continuous Learning
  • Work-life balance
  • Career growth
  • Vibrant Culture

Must Have skills

Computer Systems ValidationRegulatory complianceProject managementAnalytical skillsCommunication skills

Job Keywords

CSVvalidationregulatory complianceproject managementGxP

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