Senior Quality Assurance Specialist

2 weken geleden

Geleen, Limburg, Nederland Lonza Voltijd

At Lonza, we're committed to excellence in life sciences. As a Senior Quality Assurance Specialist, you'll play a critical role in ensuring the quality of our materials and suppliers. Your expertise will be essential in providing quality oversight of the material and supplier management process on site.

Key responsibilities include:

  • Providing quality oversight for onboarding materials on site, including reviewing and approving raw material lists and material assessments.
  • Ensuring compliance with Good Manufacturing Practices (GMP) regulations for implementation of raw materials and services used in manufacturing and supporting areas.
  • Reviewing and approving documents required for material assessment and setup, ensuring supplier/service provider qualification, and providing compliance knowledge to support resolution of material release issues and other relevant quality events.
  • Providing QA support, review, and approval for all relevant quality events (Deviation, Change Control, and CAPA).
  • Updating and revising relevant SOPs required to ensure compliance in the area of expertise.
  • Contributing to continuous improvement for topics related to material assessments, setup, and supplier/service provider qualification process.
  • Keeping up to date with compliance and regulation guidelines within the industry and supporting day-to-day compliance activities in accordance with approved procedures and policies on site.

As a subject matter expert, you'll require little direction and coaching for day-to-day activities and will be expected to be an SME to the associated workflows.

Key requirements include:

  • Bachelor's degree (Master's possible as well)
  • Related experience 2-7 years
  • Flexibility, work must be finished
  • Planning can change quickly, dynamic environment
  • English language proficiency
  • Documentation GDP (GMP)
  • QMS knowledge
  • SAP knowledge, subsystem use

At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world.

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