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QA Specialist (m/f/d) 100%

Randstad (Switzerland) Ltd.
  • Veröffentlicht:

    03 Dezember 2024
  • Pensum:

    100%
  • Arbeitsort:Visp
job details

For Lonza AG in Visp we are looking for a QA Specialist (m/f/d) 100%. This role is temporary for a minimum of 6 months.

Lonza in Visp, Switzerland, is one of the company's largest sites and a key hub for innovation and production. The site specializes in the development and manufacturing of pharmaceutical ingredients, biopharmaceuticals, and chemical intermediates. With a broad range of technologies and services, Lonza Visp supports clients in the pharmaceutical, biotechnology, and specialty chemicals sectors, providing tailored solutions for drug and specialty product manufacturing. The site plays a central role in Lonza's global value chain and drives innovation in the life sciences industry.

Key responsibilities:

  • Verification of the company's compliance with ISO/cGMP quality system requirements as well as knowledge of PICS Guide to Good Manufacturing Practices
  • Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams
  • Audit internal quality system elements in manufacturing and operational support areas.
  • Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations
  • Independently identify and manage special projects or QA compliance functions as agreed upon with QA management
  • Review and approve validation documents
  • qualifications

    • Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience
    • GMP compliance and Part 11 compliance knowledge preferred
    • Experience with oversight of aseptic processing and the associated international aseptic processing regulations
    • Excellent written and oral communication to include accurate and legible documentation skills
    • The ability to interface and communicate directly with clients is required

Nikolina Babic