Quality Assurance Specialist

2 dagen geleden


Geleen, Limburg, Nederland Lonza Voltijd
Join Our Team as a QA Method Specialist

Lonza is a global leader in life sciences, operating across three continents. Our success is built on talented people working together to devise innovative solutions that help businesses improve lives. In return, we empower our employees to own their careers, driving meaningful impact through their ideas and expertise.

The QA Method Specialist will play a critical role in ensuring the quality and compliance of our analytical methods, manufacturing processes, and shipping procedures. This involves reviewing and approving documentation, overseeing qualification and validation activities, and providing validation knowledge support to projects.

Key Responsibilities:

  • Oversee method and process verification, qualification, and validation deliverables
  • Review and approve process FMEA for the assessment of process parameters
  • Ensure correct application of validation requirements
  • Understand cGMPs, GAMP, ICH Q7A, and validation practices (IQ/OQ/PQ) and their application in practice
  • Contribute to long-term strategic development of validation programs and related plans and projects
  • Own QA-related quality system deliverables (CAPA, Change Control) and use project management skills to coordinate activities, drive timely results, and limit compliance risks

Key Requirements:

  • Education: B.Sc. or M.Sc. in Biology, Biomedical Science, Life Science, or related discipline
  • Dutch working permit
  • English language skills, fluent
  • GMP experience
  • Relevant experience, at least 3 years in Quality Control, Validation, Manufacturing Science, and Technology
  • Dutch working permit
  • Flexibility in getting the job done with appropriate quality level
  • Problem-solving ability with a holistic approach

At Lonza, we respect and protect our people and the environment. Our success is not just about achieving business results, but also about doing so ethically. We offer a challenging and creative work environment where you can make a meaningful difference in people's lives.



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