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
Requirements
Master degree or PhD 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.
Benefits
An agile career and dynamic working culture
An inclusive and ethical workplace
Compensation programs that recognize high performance
A variety of benefits dependant on role and location
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