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LO
Lonza
yesterday

Functional Lead QA CSV(m/w/x)

Visp
Full-timeOn-siteSenior

Description

As a functional lead, you will drive site-wide CSV governance and data integrity. You'll balance strategic decision-making with hands-on project oversight to ensure the site remains inspection-ready.

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Requirements

  • Degree in Computer Science, Engineering, Life Sciences or similar
  • Experience in pharma/biotech QA, CSV and Data Integrity
  • Knowledge of GxP, Annex 11, 21 CFR Part 11 and GAMP 5
  • Understanding of system lifecycle and computerized systems
  • Strategic mindset, decision-making and stakeholder alignment skills
  • Experience in audits/inspections related to CSV & DI
  • Excellent communication skills in English & German

Education

Bachelor's degree

Work Experience

approx. 4 - 6 years

Tasks

  • Define and maintain the site CSV strategy
  • Align strategies with global standards and regulatory requirements
  • Act as the QA CSV authority in projects
  • Ensure compliant system lifecycle management
  • Evaluate digital technologies for CSV and Data Integrity controls
  • Drive harmonization and global alignment of CSV processes
  • Make strategic decisions on CSV risks and validation approaches
  • Present local CSV strategies during audits and inspections
  • Approve key CSV deliverables and inspection-ready documentation
  • Provide SME support and cross-functional guidance

Tools & Technologies

CSVData IntegrityGxPAnnex 1121 CFR Part 11GAMP 5

Languages

EnglishBusiness Fluent

GermanBusiness Fluent

Benefits

Bonuses & Incentives

  • Performance-based compensation programs

Corporate Discounts

  • Lifestyle benefits
  • Leisure benefits

Family Support

  • Family benefits

Learning & Development

  • Agile career opportunities

Startup Environment

  • Dynamic work culture

Purpose-Driven Work

  • Inclusive and ethical workplace

Other Benefits

  • Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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