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Senior Quality Assurance Specialist

vor 2 Monaten


Visp, Schweiz Lonza Vollzeit
About the Role

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Lonza. As a key member of our Vibe-X QA Operations team, you will be responsible for ensuring the buildup and execution of cGMP compliant manufacturing and documentation processes in Vibe-X.

Key Responsibilities
  • Partner with internal customers to ensure quality topics are addressed in the setup of electronic batch records (eBR) in the Vibe-X project.
  • Check and approve master production records and electronic master batch records (EMBR) for consistency with approval documents, process descriptions, transfer documents, test plans, parameter lists, etc.
  • Review executed batch records within defined timelines.
  • Review minor deviations, investigations, and CAPAs within defined due dates.
  • Ensure batch records are closed and archived when all batch-related activities are completed.
  • Contribute to the management and tracking of Key Performance Indicators (KPIs) and Quality metrics, and support the QA department in internal and external meetings.
Requirements
  • Bachelor or Master of Science in chemistry, biotechnology, life sciences, or a related field is an advantage.
  • Experience in the GMP-regulated pharmaceutical/API industry.
  • Ability to recognize non-compliance and gaps in quality standards.
  • Structured, precise, and well-organized work attitude; open-minded to new ideas and suggestions; agile, highly motivated, and dynamic.
About Lonza

Lonza is a global leader in life sciences operating across three continents. We are committed to improving lives through innovative solutions and products. Our people are our greatest asset, and we offer a dynamic and challenging work environment that fosters creativity, collaboration, and growth.