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UH
Hybrid Senior QA Specialist, Cleaning Validation
Posted 5 months ago
About the role
- Senior QA Specialist at Lonza ensuring compliance during cleaning validation processes. Supports validation teams and oversees documentation for audits and regulatory compliance in life sciences.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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