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Senior Quality Assurance Specialist

vor 2 Monaten


Visp, Schweiz Lonza Vollzeit

Job Summary:

The Lead Quality Assurance 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:

The successful candidate will operate in close cooperation with the Manufacturing Science and Technology (MSAT) and Production departments, as well as with customers and regulatory agencies, to ensure that all manufacturing processes and cleaning processes are performed and validated in compliance with cGMP requirements and internal/external quality standards.

Key Responsibilities:

  • Develop and implement a Process Validation strategy in conjunction with MSAT.
  • Participate as a Quality and Compliance representative in cross-functional technical project teams.
  • Define and implement a Cleaning Validation strategy, and process-specific cleaning validation activities in conjunction with MSAT.
  • Coordinate Quality and Compliance objectives during project phases with regard to Process and Cleaning Validation activities.
  • Support and approve Quality Risk Analysis related to manufacturing processes and equipment cleaning.
  • Review and approve Process and Cleaning Validation-related documents (plans, protocols, reports).
  • Review and approve periodic reports related to the process and cleaning lifecycle (Continued Process Verification (CPV) / Annual Cleaning Review).
  • Ensure accuracy of data detailed within process and cleaning validation reports.
  • Support specific projects in process and cleaning validation area of expertise to develop further the quality standard.
  • Review and approve Process and Cleaning Validation-related documents related to Deviation, OOS Investigations, Change Requests, and CAPAs.
  • Support internal, stakeholder, and regulatory audits and inspections.

Requirements:

  • Bachelor's, Master's, or Ph.D. in Biotechnology, Pharmacy, Microbiology, Chemistry, Engineering, or related field.
  • 5+ years of experience in the area of biopharmaceutical manufacturing, preferably in a QA/qualification/validation/MSAT function, as well as a strong background in cGMPs.
  • Good communication skills and interaction with all kinds of interfaces within the organization, with customer representatives, and with regulatory agencies.
  • Fluency in English, and German would be an advantage.

About Lonza:

Lonza is a global leader in life sciences operating across three continents. Our products and services have a positive impact on millions of people. We respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

We offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.