Senior QA Specialist, Cleaning Validation 80-100% (f/m/d)
On-siteVisp, Valais, Switzerland
Job Summary
Support validation specialists throughout the cleaning validation lifecycle to ensure compliance with Lonza procedures and regulatory guidance. Review and approve critical documents including soil characterization studies, risk assessments, protocols, and annual cleaning review reports. Collaborate with Cleaning Development teams during the development phase to refine cleaning strategies and swab position assessments. Ensure validation procedures are consistently implemented and further developed at the Visp site while participating in internal and external audits. Requires a degree in Chemistry or Biotechnology with significant biopharmaceutical manufacturing experience in a validation function.
Required Qualifications
- Academic degree in Chemistry/ Biotechnology or any related field
- Significant experience in the area of biopharmaceutical manufacturing
- Experience in a validation function
- Strong background in cGMP
- Broad knowledge of manufacturing processes in GMP environment
- Experience in interacting with all kind of interfaces within the organization
- Experience interacting with regulatory agencies (Swissmedic, FDA etc.)
- Fluency in English language
Desired Qualifications
- good German language skills
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