Lead Quality Assurance Manager

Vor 6 Tagen


Visp, Schweiz Lonza Vollzeit

Job Summary:

The Lead QA Manager will play a key role in ensuring the quality and compliance of manufacturing processes and cleaning processes for equipment throughout their lifecycle at Lonza's Biologics organization.

About the Role:

This is a challenging opportunity for a highly skilled and experienced Quality Assurance professional to join our team and contribute to the development and implementation of quality standards and processes.

Key Responsibilities:

  • Develop and implement Process Validation strategies in collaboration with the Manufacturing Science and Technology (MSAT) department.
  • Ensure compliance with cGMP requirements and internal/external quality standards.
  • Coordinate Quality and Compliance objectives during project phases.
  • Support and approve Quality Risk Analysis related to manufacturing processes and equipment cleaning.
  • Review and approve Process and Cleaning Validation related documents.
  • Ensure accuracy of data in process and cleaning validation reports.
  • Support specific projects in process and cleaning validation area of expertise.

Requirements:

  • BSc, MSc, or PhD in Biotechnology, Pharmacy, Microbiology, Chemistry, Engineering, or related field.
  • 5+ years experience in biopharmaceutical manufacturing, preferably in a QA/qualification/validation/MSAT function.
  • Strong background in cGMPs and good communication skills.
  • Fluency in English, and German would be an advantage.

About Lonza:

Lonza is a global leader in life sciences operating across three continents. We are committed to improving lives through innovative solutions and a strong focus on quality and compliance.



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