Senior QA Specialist, Cleaning Validation

Senior QA Specialist, Cleaning Validation

Lonza

Visp, Switzerland

What you will do:

• Support the validation specialists during the whole lifetime of the cleaning validation to ensure compliance with Lonza procedures and regulatory guidance;
• QA Review and approval of validation documents (Soil characterization studies, risk assessments/ validation protocols and reports);
• Support Cleaning Development teams during the development phase. Review and approve Cleaning strategy paper, Swab position assessments etc.;
• QA Review and approval of Annual cleaning review reports;
• Ensure the validation procedures are consistently implemented and further developed at Lonza Visp;
• Participation in audits and inspections.

What we are looking for:

• Academic degree in Chemistry/Biotechnology or any related field;
• Significant experience in the area of biopharmaceutical manufacturing, preferably in a validation function as well as strong background in cGMP;
• Broad knowledge of manufacturing processes in GMP environment;
• Experience in interacting with all kind of interfaces within the organization as well as with regulatory agencies (Swissmedic, FDA etc.);
• Fluency in English language required, good German language skills would be an advantage.