CSV Senior Specialist (m/f/o)

Tasks

• Lead CSV projects, ensuring systems meet regulatory and data integrity standards from validation through to operational use
  
• Assess and manage changes to software and hardware, performing thorough risk analyses and ensuring validation lifecycle compliance
  
• Develop, execute, and maintain CSV protocols and documentation in line with FDA, EU GMP, and corporate standards
  
• Act as the CSV Subject Matter Expert during internal and external audits
  
• Support equipment qualification activities and coordinate with vendors for related periodic qualifications
  
• Contribute to quality investigations (e.g., deviations, CAPAs, complaints) in collaboration with the Quality Unit

Requirements

• Graduate level qualification in a relevant field, preferably life sciences, combined with a strong IT background
  
• Previous hands-on experience in CSV within a regulated pharmaceutical or life sciences environment
  
• Solid understanding of industry standards such as GAMP 5, with practical experience applying risk-based approaches to computerized systems validation and data integrity
  
• Strong attention to detail with proven ability to produce clear, accurate, and compliant validation documentation
  
• Proven ability to prioritize and lead tasks in a dynamic, compliance-driven environment

Viviana Costa